Comparison of sedation efficacy and safety between dexmedetomidine and propofol during endoscopic retrograde cholangiopancreatography: A prospective, randomized, single-blinded trial

doi:10.21203/rs.3.rs-1976991/v2

Download PDF

Research Article

Comparison of sedation efficacy and safety between dexmedetomidine and propofol during endoscopic retrograde cholangiopancreatography: A prospective, randomized, single-blinded trial

https://doi.org/10.21203/rs.3.rs-1976991/v2

This work is licensed under a CC BY 4.0 License

Version 2

posted

You are reading this latest preprint version

What is known and objective: Propofol-balanced sedation is widely used in endoscopic retrograde cholangiopancreatography (ERCP) procedures, but sedation-related adverse events (SRAEs) commonly occur. The combination of dexmedetomidine with opioids and benzodiazepines has provided effective sedation with a superlative degree of safety during different clinical scenarios. The aim of this study was to compare the sedation efficacy and safety between dexmedetomidine and propofol with a balanced administration of opioids and benzodiazepines during ERCP procedures.

Methods: Forty-one patients were randomly divided into two groups, the dexmedetomidine (DEX) group and the propofol (PRO) group. As a premedication, all participants received an intravenous bolus dose of 0.02 mg·kg^-1 midazolam and 0.2 μg·kg^-1 sufentanil. Patients in the DEX group received an additional bolus of 0.6 μg·kg^-1 dexmedetomidine over 2 min followed by a dexmedetomidine infusion at 1.2 μg·kg^-1·h^-1, whereas the PRO group received 1–2 mg·kg^-1propofol bolus over 30 s followed by a propofol infusion at 2–3 mg·kg^-1·h^-1. The primary outcome was the incidence of hypoxemia (SpO₂< 90% for > 10 s) during ERCP.

Results: All patients achieved the targeted sedation level on the Ramsay Sedation Scale ³ 4. When compared with the PRO group, the incidence of hypoxemia was significantly reduced in the DEX group. Respiratory depression (respiratory rate of < 10 bpm·min^-1) was more frequently observed among PRO patients than DEX patients. During the procedures, endoscopists’ and patients’ satisfaction scores were comparable between groups, as were patients’ pain and amnesia scores.

What is new and conclusion: Dexmedetomidine provided satisfactory sedation safety with no downstream effects on sedation efficacy when performing ERCP in comparison with propofol in combination with opioids and benzodiazepines.

endoscopic retrograde cholangiopancreatography

dexmedetomidine

propofol

sedation-related adverse events

Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure commonly used for diagnostic or therapeutic purposes in pancreaticobiliary pathology, with the patient in a prone or semiprone position. Sedation and anesthesia are usually required to relieve patient anxiety and discomfort, improve examination outcomes, and diminish the patients’ memory of the event. It is noteworthy that anesthesia care standards for ERCP have not been established and sedation practice patterns vary substantially worldwide [1].

Many sedative medications, with different anesthetic mechanisms, are used to provide appropriate sedation and anesthesia levels for ERCP. Historically, ERCP was performed under moderate sedation using opioids and benzodiazepines, with or without adjunctive agents; however, moderate sedation was largely abandoned due to insufficiency leading to premature completion [2,3]. Propofol or dexmedetomidine as adjuncts to moderate sedation have been considered in recent decades [4,5]. Propofol is used for painless endoscopy due to its rapid onset of action and short half-life; however, it causes cardiovascular inhibition and dose-dependent respiratory depression, thereby necessitating constant supervision by appropriately trained anesthesia professionals [6,7]. Moreover, the prone or semiprone position during ERCP may be associated with altered cardiopulmonary physiology and limited airway access [8]. Therefore, airway management may be further complicated and difficult in worst-case scenarios under propofol sedation.

Dexmedetomidine is a highly selective α-2-adrenoceptor agonist and provides analgesia and sedation with minimal cardiopulmonary compromise at clinically deep sedation levels. Recently, several investigations showed dexmedetomidine exerted synergistic effects in combination with opioids and benzodiazepines, and provided adequate procedural sedation similar to propofol in different clinical scenarios [9–11]. However, dexmedetomidine may cause bradycardia and sympathetic inhibition [12]. While both sedatives have their advantages and disadvantages, to the best of our knowledge, no agreement has been achieved on the best sedation regimen to facilitate ERCP procedures in an effective, safe, and satisfying manner.

When considering previous evidence on dexmedetomidine efficacy and safety, we hypothesized that the drug combined with opioids and benzodiazepines could reduce the incidence of cardiopulmonary adverse events concomitant with equally satisfactory sedation conditions for the endoscopist and patient during ERCP procedures, when compared with sedation by propofol. Furthermore, midazolam is the first choice of benzodiazepine for fast-acting, reversible, and retrograde amnesia effects. Sufentanil has high potency and affinity to the opioid receptor, with weak respiratory depression. Hence, combined sufentanil and midazolam administration was used as the basic ERCP medication throughout our study.

We designed this study to compare sedation efficacy and safety between dexmedetomidine and propofol with balanced sufentanil and midazolam administration during ERCP procedures.

2.1 Design and patients

This study was approved by the Medical Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University and was registered in the Clinical Trial Registration Center of China (ChiCTR2200061468). Patients scheduled for an ERCP procedure between June 2022 and August 2022 were eligible to be enrolled in this prospective, randomized, single-blind study if they were aged between 18 to 80 years and had American Society of Anesthesiologists (ASA) physical status I–III. Exclusion criteria were ASA physical status IV–V, refusal to participate, pregnant or breast-feeding patients, allergy history to study medication, and long-term sedative or narcotic analgesic drug abuse. Written informed consent was obtained from all patients.

2.2 Anaesthetic procedure

Patients fasted for at least 6 h before ERCP. After intravenous access was obtained, an infusion of 500 mL Ringer’s solution was started at a rate of 250 mL·h^-1. Patients were placed in a semiprone position and 2 L·min^-1 oxygen was given through a nasal cannula. Patients received laryngopharynx topical anesthesia with 2% lidocaine, an intravenous dose of 0.2 μg·kg^-1 sufentanil and 0.02 mg·kg^-1 midazolam as premedication. Additionally, the DEX group received an initial bolus of 0.6 μg·kg^-1 dexmedetomidine over 2 min followed by a dexmedetomidine infusion at 1.2 μg·kg^-1·h^-1. The PRO group received an initial bolus of 1–2 mg·kg^-1 propofol over 30 s followed by a propofol infusion at 2–3 mg·kg^-1·h^-1. We targeted a sedation level on the Ramsay Sedation Scale (RSS, Table 1) ³ 4. In case of RSS < 4 or intolerance of the procedure, 0.1 μg·kg^-1 sufentanil and 0.01 mg·kg^-1 midazolam were used as rescue drugs.

TABLE 1 Ramsay Sedation Scale
Sedation score	Response
1	Anxious and agitated or restless, or both
2	Co-operative, oriented, and tranquil
3	Responding to commands only
4	Brisk response to light glabellar tap or loud auditory stimulus
5	Sluggish response to light glabellar tap or loud auditory stimulus
6	No response to stimulus

2.3 Measurement

Baseline demographic data including age, gender, and body mass index were measured preoperatively. The sedation level was assessed using RSS for clinical scoring and the bispectral index (BIS) as an objective tool. During the procedure, heart rate (HR), oxygen saturation (SpO₂), respiratory rate (RR), mean blood pressure (MAP), RSS, and BIS levels were monitored and recorded at the following time points: 5 min before sedation (baseline, T₀), 5 min after sedation (T₁), 0, 5, 10, 15, 20 min after starting ERCP (T₂–T₆), and post-procedure 0, 5, 10 min (T₇–T₉).After the procedure, patients were observed in the recovery unit for at least 30 min. Recovery status was assessed using the modified Aldrete Score [13]. Patients were ready for discharge when this score was at least 9 without substantial side effects such as nausea and dizziness.

Time to achieve RSS ³ 4 was recorded as the onset time of targeted sedation. Recovery time was measured from the end of ERCP to achievement of a modified Aldrete Score of 9. Rescue drug injections were recorded. Immediately after the procedure, endoscopists were asked to rate their satisfaction: 1) satisfied, 2) mild dissatisfied, 3) severe dissatisfied, and 4) unbearable. On the day after the procedure, the satisfaction score, pain, and amnesia of the patients were evaluated by an anesthesia resident as following: satisfaction: 1) comfortable, 2) mild discomfort, 3) severe discomfort, and 4) unbearable). Pain: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain. Amnesia: 1) I do not remember any part of the procedure, 2) I remember some parts of the procedure, and 3) I completely remember the procedure.

Hemodynamic and respiratory variables including MAP, HR, SpO₂, and RR were compared between groups in terms of sedation regimen safety. Perioperative adverse events included sedation-related adverse events (SRAEs) and ERCP-related adverse events. SRAEs were defined as hypoxemia (SpO₂< 90% for > 10 s), respiratory depression (RR < 10 bpm), hypotension (MAP < 65 mmHg), and bradycardia (HR < 45 beats·min^-1). If respiratory depression or oxygen desaturation was observed, supplemental oxygen was administered via the nasopharyngeal airway. Hypotension or bradycardia was treated with intravenous saline or vasoactive agents (ephedrine or atropine). ERCP-related adverse events were defined as the presence of post-ERCP pancreatitis (PEP), bleeding, perforation, and infection. Severe adverse events were defined as the requirement of tracheal intubation and/or mechanical ventilation.

2.4 Outcomes

The primary outcome was the incidence of hypoxemia. The secondary outcomes were as follows: (1) onset time of targeted sedation, recovery time, and rescue drug injections; (2) the degree of endoscopists’ and patients’ satisfaction, and patients’ pain and amnesia scores; (3) RSS, BIS, MAP, HR, SpO₂, and RR at T₀–T₉; (4) the adverse events recorded, which included respiratory depression, hypotension, bradycardia, and ERCP-related adverse events.

2.5 Statistical analysis

We hypothesized that sedation with dexmedetomidine for ERCP would reduce the incidence of hypoxemia by at least 50% when compared with sedation with propofol. Based on a previous study by Jokelainen et al. [14], 60.7% of patients had hypoxemia episodes with propofol-based sedation for ERCP. To achieve a power ≥ 0.80 and an α level = 0.05, the sample required for chi-square with Fisher’s exact test was 17 patients per group. Assuming a 10% dropout rate, the final sample size was set at 19 patients per group.

Statistical analyses were conducted using SPSS software version 26.0 (IBM, Armonk, NY, USA). An independent sample t-test and nonparametric tests were used for continuous variables. For categorical variables, Pearson’s chi-square and Fisher’s exact tests were applied for variables that expressed as numbers and/or percentages of the total. For normal distributions, continuous variables were represented as the mean ± standard deviation. Non-normally distributed data were compared using Kolmogorov-Smirnov test and data were presented as the median and interquartile range (IQR). A P value < 0.05 was considered statistically significant.

In our Gastrointestinal Endoscopy Unit, 44 eligible patients scheduled for an ERCP procedure were randomized with 22 patients per group. Two patients from the DEX group and one from the PRO group were excluded due to failed duodenal intubation. Therefore, data were finally collected from 20 and 21 patients in DEX and PRO groups, respectively, as shown in the Consort flow diagram (Figure 1).

Patient characteristics and ERCP procedure details are shown in Table 2. The mean patient age was 57 years in the DEX group and 61 in the PRO group. Patients in both groups were comparable in terms of physical characteristics and underlying comorbidities. Furthermore, no significant differences were identified between the groups in terms of indications for ERCP and the mean procedure duration (P > 0.05).

TABLE 2 Patient characteristics and ERCP procedure details
	DEX Group (n = 20)	PRO Group (n = 21)	p value
Age (y)	57.1 ± 16.1	61.0 ± 12.8	0.395
Sex (male/female, n)	9/11	9/12	0.890
BMI (kg/m²)	23.2 ± 2.6	22.7 ± 3.6	0.676
Cigarette smoking [n (%)]	4 (20.0)	1 (4.8)	0.311
Alcohol intake [n (%)]	3 (15.0)	5 (23.8)	0.477
Comorbidities [n (%)]
Cardiovascular disease	6 (30.0)	9 (42.9)	0.393
Respiratory disease	None	4 (19.0)	0.126
Diabetes	3 (15.0)	5 (23.8)	0.751
Renal disease	6 (30.0)	2 (9.5)	0.208
Liver disease	7 (35.0)	12 (57.1)	0.155
ASA status (I/II/III, n)	4/10/6	2/16/3	0.284
ERCP indications [n (%)]			0.798
Common bile duct stone	17 (85.0)	16 (76.2)
Biliary strictures	None	2 (9.5)
Gallbladder carcinoma	1 (5.0)	None
Pancreatic pathology	1 (5.0)	2 (9.5)
Other	1 (5.0)	1 (4.8)
Duration of procedures (min)	23.3 ± 11.5	25.5 ± 14.7	0.593
Note: Normally distributed data are presented as mean ± SD; categorical variables are presented as count (%). Abbreviations: ERCP, endoscopic retrograde cholangiopancreatography; DEX, dexmedetomidine; PRO, propofol; BMI, body mass index; ASA, American Society of Anesthesiologists; SD, standard deviation.

As indicated in Figure 2, RSS and BIS scores were comparable at baseline and no differences were observed at T₂–T₉time points; however, the RSS score was significantly higher while the BIS score was lower in the PRO group than those in the DEX group at T₁ time point (P < 0.05).

Sedation efficacy parameters are shown in Table 3. A faster onset of targeted sedation was observed in the PRO group when compared with the DEX group. In contrast, patients in the DEX group had decreased duration required for recovery when compared with those in the PRO group (P < 0.05). The requirements of administering rescue agents to facilitate procedures were similar between groups (P > 0.05).

TABLE 3 Parameters of Sedation Efficacy
	DEX Group (n = 20)	PRO Group (n = 21)	p value
Onset time of targeted sedation (min)	2.7 ± 1.8	1.0 ± 0.0	0.000
Recovery time (min)	1.6 ± 1.9	6.9 ± 3.2	0.002
Rescue drug injections [n (%)]	5 (25.0)	4 (19.0)	0.934
Note: Normally distributed data are presented as mean ± SD; categorical variables are presented as count (%). Abbreviations: DEX, dexmedetomidine; PRO, propofol; SD, standard deviation.

The degree of endoscopists’ and patients’ satisfaction, and patients’ pain and amnesia scores were recorded (Figure 3). Endoscopists’ and patients’ satisfaction scores were comparable between groups, while no differences were identified between groups in terms of patients’ pain and amnesia (P > 0.05).

As shown in Figure 4, no significant between-group differences were observed for the baseline variables of MAP, HR, SpO₂, and RR at T₀. Patients in the DEX group exhibited a statistically significant higher MAP after the loading dose injection at T₁, while patients exhibited a lower MAP at T₉when compared to PRO patients (P < 0.05). A statistical difference in HR was identified between the two groups from 5 min after the initiation of sedation to the procedure end. There was no difference in SpO₂between groups throughout the procedure (P > 0.05), however, RR in the PRO group was significantly lower than the DEX group at T₁ and T₂(P < 0.05).

SRAEs are indicated in Table 4. Significant differences in the incidence of hypoxemia and respiratory depression were found between groups (P < 0.05). Six patients in the PRO group and none of patients in the DEX group had hypoxemia episodes. Respiratory depression occurred in 81% of patients in the PRO group and 35% of patients in the DEX group (P < 0.05). No statistical differences were observed between the groups in terms of hypotension and bradycardia episodes (P > 0.05).

TABLE 4 Sedation-related adverse events
	DEX Group (n = 20)	PRO Group (n = 21)	p value
Hypoxemia [n (%)]	None	6 (28.6)	0.032
Respiratory depression [n (%)]	7 (35.0)	17 (81.0)	0.003
Hypotension [n (%)]	5 (25.0)	7 (33.3)	0.558
Bradycardia [n (%)]	5 (25.0)	2 (9.5)	0.367
Note: The data are presented as count (%). Abbreviations: DEX, dexmedetomidine; PRO, propofol.

ERCP-related adverse events are shown in Table 5, with no differences observed between groups. No severe adverse events occurred in either group.

TABLE 5 ERCP-related adverse events
	DEX Group (n = 20)	PRO Group (n = 21)	p value
PEP [n (%)]	5 (25.0)	4 (19.1)	0.934
Bleeding [n (%)]	None	1 (4.8)	>0.999
Perforation [n (%)]	None	None	1.000
Infection [n (%)]	6 (30.0)	4 (19.1)	0.651
Note: The data are presented as count (%). Abbreviations: ERCP, Endoscopic retrograde cholangiopancreatography; PEP, Post-endoscopic retrograde cholangiopancreatography pancreatitis; DEX, dexmedetomidine; PRO, propofol.

In this study, our data showed that a dexmedetomidine-based sedation regimen provided a superlative degree of safety, with minimal respiratory inhibition during ERCP with no downstream effects on procedural efficacy when compared with propofol sedation.

ERCP is an essential diagnostic and therapeutic method for biliary and pancreatic diseases, generally conducted under anesthesia due to its painful and time-consuming properties. Sedation without intubation administered by an anesthesiologist appears to be the most recommended strategy for ERCP due to a reduced incidence of adverse discharges [15]. Propofol is the mainstay sedative for sedation without intubation during gastrointestinal endoscopy for its outstanding character of potent action, rapid onset, and fast recovery [16]. However, doubts concerning its sedation-related side effects hinder its widespread clinical application, particularly during ERCP for elderly populations and those requiring prone positions. Indeed, previous studies reported a high incidence of hypotension (4.8%–19%) and hypoxemia or apnea (3.3%–60.7%) under propofol sedation during ERCP [6,14,17,18]. Dexmedetomidine is a highly selective α-2-adrenoceptor agonist with sedative, analgesic, and anxiolytic properties. Balanced dexmedetomidine administration with opioids and benzodiazepines could be an alternative and safer method to propofol during advanced endoscopic procedures. However, to our knowledge, the data are limited on the sedation efficacy and safety of dexmedetomidine combined with opioids and benzodiazepine administration when compared with propofol during ERCP.

Several controlled randomized trials investigated the sedation efficacy of dexmedetomidine combined with opioids and benzodiazepines during ERCP procedures [4,19]. Lu et al. [4] demonstrated that 95% of patients completed ERCP without discomfort and additional sedative use under dexmedetomidine and remifentanil anesthesia. Ikeda and colleagues [19] showed that combination treatment with dexmedetomidine and benzodiazepines provided high-quality sedative effects with rare excessive movement. Consistent with previous results, all patients in our study achieved the targeted RSS sedation level and completed the procedure without premature termination. Moreover, RSS sedation levels and BIS scores were similar between groups after bolus administration with no significant differences in the requirement of rescue agents.

A previous meta-analysis reported that propofol provided a higher level of satisfaction when compared with dexmedetomidine in patients undergoing gastrointestinal endoscopy [20], while another meta-analysis demonstrated a higher satisfaction of endoscopic performers were rated for dexmedetomidine-based sedation when compared with propofol [21]. In the present study, we demonstrated comparable satisfaction levels among endoscopic performers and patients when different anesthetic agents were used. Such a discrepancy may be attributed to the synergistic effects of opioids and benzodiazepines when added to dexmedetomidine sedation [10]. Additionally, the effect of suppressing gastric motility with dexmedetomidine-based sedation may contribute to the improved endoscopist satisfaction when compared with propofol [11]. Above all, our study showed that both sedating regimens provided equivalent sedation efficacy with relatively satisfactory levels of sedation.

It was worth noting that the sedation depth was transiently deeper at T₁ in the PRO group compared to the DEX group. This was due to the rapid onset of propofol activity, which was further verified by the shorter onset time of targeted sedation in the PRO group compared to the DEX group. In terms of shorter onset times, this may be a double-edged sword for sedation. As shown in Figure. 4, MAP and RR were significantly lower in the PRO group at T₁. This finding reflected the narrow therapeutic index of propofol and the risk of cardiovascular complications, especially during the induction period. This indicated a difficulty in controlling cardiorespiratory stability with propofol, especially in the elderly, by an unexperienced anesthesiologist or under nurse-guided sedation [22]. In contrast, patients in the DEX group had a faster recovery than the PRO group due to the unusual property of its arousable sedation [10]. Patients in the DEX group were aroused immediately by name calling or a shake stimulus after ERCP. Additionally, dexmedetomidine enabled patients to achieve an Aldrete score of 9 at the procedure end and to leave the operation room within 2 min.

Respiratory and cardiovascular suppress are well known as the side effects of propofol. The features that differentiate dexmedetomidine from propofol are the maintenance of spontaneous breathing and the avoidance of profound cardiovascular compromise during sedation. In our study, MAP was lower after induction but higher during the recovery period under propofol sedation when compared with dexmedetomidine. The short elimination half-life of propofol may be responsible for these differences, in contrast, dexmedetomidine has a relatively slow elimination with cumulative effects leading to prolonged cardiovascular depression [23]. Consequently, dexmedetomidine and propofol may have similar hypotension risks which may occur throughout the procedure. Dose-dependent respiratory depression is another major concern for propofol treatment [6]. In our study, airway manipulation due to transient hypoxemia was required in 29% of patients, while 81% of cases exhibited a respiratory rate < 10 bpm in the PRO group. Although no different effects on SpO₂ were observed between the two segments, fluctuations in values were obvious under propofol sedation. These results agreed with Yang et al. [24] who showed that 28% of patients experienced hypoxemia during propofol sedation. For dexmedetomidine, its major issue is bradycardia resulting from α 2-adrenoceptor activation, and we observed a lower heart rate in the DEX group throughout the study, which could be immediately reversed by treatment with atropine.

In recent years, several case reports suggested an association between short-term exposure to propofol and acute pancreatitis [25,26], therefore propofol sedation has raised additional concerns for increasing PEP risk. Our ERCP procedure lasted for 25 min on average, and our results showed that such a short-term exposure to propofol exhibited a similar risk to dexmedetomidine in terms of PEP, consistent with Li et al. [27]. Furthermore, previous investigations indicated that dexmedetomidine may provide superior anti-inflammatory effects and decrease infection risk [28]. However, no significant differences in the incidence of post-ERCP infections were observed between groups. Based on these data, propofol or dexmedetomidine sedation are comparatively safe anesthetics strategies for ERCP without increasing additional risk of ERCP-related adverse events.

The standard recommendation for dexmedetomidine administration method is complicated, as the loading dose should be given over 10 min followed by an infusion rate of 0.7–1.4 μg·kg^-1·h^-1[12]. However, data from previous studies demonstrated that 0.5 μg·kg^-1 dexmedetomidine could be used as a bolus within 30 s in patients without causing any substantial hemodynamic compromise [18,29]. Therefore, a 0.6 μg·kg^-1 loading doses of dexmedetomidine over 2 min, alternating with sufentanil and midazolam, were used in our study.

Our study had several limitations. (1) The endoscopist was assumed to be blinded to group assignment, but it was still uncertain whether they could identify sedative agents in terms of physical property differences between dexmedetomidine and propofol. Therefore, we could not eliminate the personal bias when they answered the questionnaires. (2) Our study included patients with ASA status I–III and < 80 years old in a single center. Older age and an ASA status of III or higher were demonstrated to be independent predictors of developing SRAEs under propofol sedation [24]. Additionally, the beneficial effects of dexmedetomidine-based sedation may have been more apparent in critically ill patients, this factor may have skewed our results.

Both dexmedetomidine and propofol-based sedating regimens exhibited satisfactory sedative efficacy for ERCP. Dexmedetomidine, in combination with opioids and benzodiazepines, offered distinct advantages in sedation safety due to a lower incidence of respiratory adverse events during ERCP when compared with propofol. Therefore, dexmedetomidine could be an ideal substitute to propofol for patients undergoing ERCP.

CONFLICT OF INTEREST

The authors declare no competing interests.

INFORMED CONSENT

All patients participating in the clinical trial provided written informed consent.

DATA AVAILABILITY STATEMENT

The data used to support the findings of this study are available from the corresponding author upon request.

1. Early DS, Lightdale JR, Vargo JJ 2nd, et al. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2018;87:327–37.

2. Raymondos K, Panning B, Bachem I, et al. Evaluation of endoscopic retrograde cholangiopancreatography under conscious sedation and general anesthesia. Endoscopy. 2002;34:721–6.

3. Jeurnink SM, Steyerberg E, Kuipers E, et al. The burden of endoscopic retrograde cholangiopancreatography (ERCP) performed with the patient under conscious sedation. Surg Endosc. 2012;26:2213–9.

4. Lu Z, Li W, Chen H, Qian Y, et al. Efficacy of a Dexmedetomidine-Remifentanil Combination Compared with a Midazolam-Remifentanil Combination for Conscious Sedation During Therapeutic Endoscopic Retrograde Cholangio-Pancreatography: A Prospective, Randomized, Single-Blinded Preliminary Trial. Dig Dis Sci. 2018;63:1633–40.

5. Haytural C, Aydınlı B, Demir B, et al. Comparison of Propofol, Propofol-Remifentanil, and Propofol-Fentanyl Administrations with Each Other Used for the Sedation of Patients to Undergo ERCP. BioMed Res Int. 2015;2015:465465.

6. Park CH, Park SW, Hyun B, et al. Efficacy and safety of etomidate-based sedation compared with propofol-based sedation during ERCP in low-risk patients: a double-blind, randomized, noninferiority trial. Gastrointest Endosc. 2018;87:174–84.

7. Liu J, Liu X, Peng LP, et al. Efficacy and safety of intravenous lidocaine in propofol-based sedation for ERCP procedures: a prospective, randomized, double-blinded, controlled trial. Gastrointest Endosc. 2020;92:293–300.

8. Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008;100:165–83.

9. Lee BS, Ryu J, Lee SH, et al. Midazolam with meperidine and dexmedetomidine vs. midazolam with meperidine for sedation during ERCP: prospective, randomized, double-blinded trial. Endoscopy. 2014;46:291–8;

10. Weerink MAS, Barends CRM, Muskiet ERR, et al. Pharmacodynamic Interaction of Remifentanil and Dexmedetomidine on Depth of Sedation and Tolerance of Laryngoscopy. Anesthesiology. 2019;131:1004–17.

11. Kim N, Yoo YC, Lee SK, et al. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015;21:3671–8.

12. Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015;75:1119–30.

13. Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995;7:89-91.

14. Jokelainen J, Belozerskikh A, Mustonen H, et al. Doxapram as an additive to propofol sedation for endoscopic retrograde cholangiopancreatography: a placebo-controlled, randomized, double-blinded study. Surg Endosc. 2020;34:5477–83.

15. Althoff FC, Agnihotri A, Grabitz SD, et al. Outcomes after endoscopic retrograde cholangiopancreatography with general anaesthesia versus sedation. Br J Anaesth. 2021;126:191–200.

16. Cheriyan D, Byrne MF. Propofol use in endoscopic retrograde cholangiopancreatography and endoscopic ultrasound. World J Gastroenterol. 2014;20:5171–6;

17. Ogawa T, Tomoda T, Kato H, et al. Propofol sedation with a target-controlled infusion pump in elderly patients undergoing ERCP. Gastrointest Endosc. 2020;92:301–7.

18. Goyal R, Hasnain S, Mittal S, et al. A randomized, controlled trial to compare the efficacy and safety profile of a dexmedetomidine-ketamine combination with a propofol-fentanyl combination for ERCP. Gastrointest Endosc. 2016;83:928–33.

19. Ikeda Y, Yoshida M, Ishikawa K, et al. Efficacy of combination therapy with dexmedetomidine for benzodiazepines-induced disinhibition during endoscopic retrograde cholangiopancreatography. Therap Adv Gastroenterol. 2020;13:1756284820911822.

20. Nishizawa T, Suzuki H, Hosoe N, et al. Dexmedetomidine vs propofol for gastrointestinal endoscopy: A meta-analysis. United European Gastroenterol J. 2017;5:1037–45.

21. Chen YT, Sun CK, Wu KY, et al. The Use of Propofol versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021;10:1585.

22. Coté GA, Hovis RM, Ansstas MA, et al. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010;8:137–42.

23. Eberl S, Preckel B, Bergman JJ, et al. Satisfaction and safety using dexmedetomidine or propofol sedation during endoscopic oesophageal procedures: A randomised controlled trial. Eur J Anaesthesiol. 2016;33:631–7.

24. Yang JF, Farooq P, Zwilling K, et al. Efficacy and Safety of Propofol-Mediated Sedation for Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). Dig Dis Sci. 2016;61:1686–91.

25. Csomor J, Murínová I, Broulíková K, et al. Propofol-induced acute pancreatitis. J Clin Pharm Ther. 2017;42:495–8;

26. Gottschling S, Larsen R, Meyer S, et al. Acute pancreatitis induced by short-term propofol administration. Paediatr Anaesth. 2005;15:1006–8.

27. Li N, Tieng A, Novak S, et al. Effects of medications on post-endoscopic retrograde cholangiopancreatography pancreatitis. Pancreatology. 2010;10:238–42.

28. Riker RR, Shehabi Y, Bokesch PM, et al. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009;301:489–99.

29. Dawes J, Myers D, Görges M, et al. Identifying a rapid bolus dose of dexmedetomidine (ED50) with acceptable hemodynamic outcomes in children. Paediatr Anaesth. 2014;24:1260–7.

6.CONSORTChecklist2010.doc

Download PDF

Version 2

posted

You are reading this latest preprint version

Comparison of sedation efficacy and safety between dexmedetomidine and propofol during endoscopic retrograde cholangiopancreatography: A prospective, randomized, single-blinded trial

Status:

Version 2

Abstract

Figures

Introduction

Method

Results

Discussion

Conclusion

Declarations

References

Supplementary Files

Status:

Version 2