Comparison of the effect of three different sub-dissociative doses of ketamine on the quality of sedation in flexible fiber optic bronchoscopy

doi:10.21203/rs.3.rs-3301260/v1

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Comparison of the effect of three different sub-dissociative doses of ketamine on the quality of sedation in flexible fiber optic bronchoscopy

https://doi.org/10.21203/rs.3.rs-3301260/v1

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Background: Reducing the patient's anxiety and stress is necessary to facilitate fiberoptic (flexible) bronchoscopy. This study was conducted with the aim of comparing the effect of three sub anesthetic doses of ketamine on the quality of sedation in bronchoscopy.

Methods: This clinical trial study was conducted from November 2020 until May 2021 in Al-Zahra (S) and Khorshid hospitals in Isfahan, 90 patients who were candidates for flexible fiberoptic bronchoscopy (FFB) was randomly entered into the study in three groups of 30 people. In the first group (k1) Ketamine 0.2mg/kg, in the second group (K2) Ketamine 0.4mg/kg and in the third group (k3) Ketamine 0.5mg/kg intravenously (IV) Prescribed. In all patients, propofol was administered through a pump syringe containing 15 ml of propofol. First, a bolus dose of 0.4 mg/kg was injected, and then the infusion of propofol continued at a rate of 50-100 µg/kg/min through bronchoscopy. After reaching level 4 of sedation based on the Ramsey sedation criteria, bronchoscopy was started. The quality of sedation and its duration, the duration of bronchoscopy, the satisfaction of the patient and the bronchoscopist were evaluated and recorded. Data analysis was done using SPSS version 23 software (USA, NY, Armonk, SPSS IBM) and Mann-Whitney-U tests, student t-test, chi-square and analysis of variance with repeated observations.

Results: In terms of demographic variables including age ((P=0.56)), gender ((P=0.22)) and ASA class ((P=0.69)) there were no significant differences between the three groups. The average score of sedation and duration of sedation in k3 group is more than K2 in both. It was more than k1 (P>0.001). The level of satisfaction of treating doctor (P=0.78) and patient (P=0.019) in k3 group was higher than other groups. The dose of propofol received in k3 group was lower than K2 and in both groups it was lower than k1 (P>0.001). Changes in systolic, diastolic and average blood pressure were not significantly different between the three groups (p>0.05).

Discussion: Sedation regimens using ketamine appear to be appropriate for adult FFB. Increasing the sub-anesthetic dose of ketamine from 0.2 mg/kg to 0.5 mg/kg in combination with propofol is associated with an increase in Ramsey's sedation score, an increase in patient and physician satisfaction, and a decrease in propofol consumption. For fiberoptic (flexible) bronchoscopy in adults, a dose of 0.5 mg/kg may be preferable to other doses.

The aforementioned trial has been duly registered with the Clinical Trials Registration Center of Iran under the identification number IRCT20180416039326N17, with the registration date being the 10/12/2020

Sedation

Fiberoptic Bronchoscopy (flexible)

Ketamine

Propofol

Flexible bronchoscopy is the gold standard for viewing the airways, which allows multiple diagnostic and therapeutic interventions (1). Flexible bronchoscopy (FB), which is performed awake or under local anesthesia, is a difficult and complex procedure for patients and physicians. Presently, it is advised that FFB be conducted with sedation in all instances, provided there are no contraindications (2). Sedation is used during FFB procedures to facilitate airway examination, reduce patient movement, and improve patient safety. Sedation can be induced with drugs such as benzodiazepines (such as midazolam), opioids (such as fentanyl), propofol, and ketamine. There is no standard method for the use of sedation in bronchoscopy (1, 3). In procedures under sedation, an intravenous induction agent or a combination of induction agents with a quick and gentle onset and with recovery with minimal hemodynamic changes and side effects is our ideal.

Ketamine and propofol both have a quick and mild onset of effect, although they have obvious and adverse hemodynamic effects, if they are used alone as an induction agent in high-risk patients, they can be associated with harmful effects (4, 5). Ketamine has been used in flexible bronchoscopy, particularly for the pediatric population. (6) The safety and efficacy of ketamine in sedation of adults undergoing FFB have not been fully investigated (3).

Ketamine is a phencyclidine derivative with sedative and analgesic properties that can be used alone or in combination for diagnostic and therapeutic procedures (8, 9). Ketamine provides an anesthetic effect and provides amnesia and extraordinary analgesia. Along with maintaining muscle tone, protection of airway reflexes and continuous spontaneous breathing. Propofol has amnesia, anti-nausea and anti-convulsing properties. It produces a rapid response and has a short recovery time (10), however, since propofol does not have an analgesic effect, it is recommended for use in procedural sedation with ketamine or short-term narcotics (11).

Propofol is a non-opioid and non-barbiturate sedative drug that has anti-nausea properties and its side effects include dose-dependent cardiovascular and respiratory suppression. Propofol has a short duration of action of 2–4 minutes, followed by a short period of recovery. The patient and recovery takes about 10–20 minutes (12).

In the review of the literature, no study was found on the effect of different sub anesthetic doses of ketamine on the quality of sedation in short-term procedures such as fiberoptic (flexible) bronchoscopy. Therefore, the present study was conducted with the aim of comparing the effect of three different doses of ketamine on the quality of sedation in bronchoscopy.

Study design:

This prospective, randomized, double-blind trial, after obtaining permission from the Ethics Committee of Isfahan University of Medical Sciences with the code IR.MUI.MED.REC.1399.704 and registration in the Iranian Clinical Trial Center with the identifier IRCT20180416039326N17 (date: 10/12/2020), from November 2020 until May 2021 was performed on 90 patients (3 groups of 30) candidate for Fiberoptic (flexible) bronchoscopy in Al-Zahra (S) and Khorshid hospitals, Isfahan.

Participants

Inclusion Criteria

Participants who met the criteria of being of age 18 or older, possessing American Society of Anesthesiologists physical status I‒II, and consenting in written form were included in the study.

Criteria for not entering and exclusion the study

Patients with brain disorders, chronic users of sedative drugs, alcohol and narcotic users, patients with a history of allergy to the drugs used in the study, and those receiving sedatives or painkillers within 24 hours before the bronchoscopy, were not included in the study. The occurrence of a severe allergic reaction to any of the drugs used and the occurrence of adverse events leading to a change in the anesthesia plan or hospitalization of the patient in the intensive care unit were considered as exclusion criteria.

Interventions

Before performing bronchoscopy, the patients underwent initial evaluation in the anesthesia clinic, and those who met the entry criteria, after obtaining informed consent were selected, and their demographic characteristics were measured and recorded in the relevant form.

When the patients entered the bronchoscopy unit, they were placed on the bed in supine position and continuous monitoring including electrocardiogram, pulse oximetry, intermittent non-invasive blood pressure and capnograph were connected to the patient. The basic variables of blood pressure, heart rate and oxygen saturation of peripheral blood were measured and recorded. The participants receiving 4 L/min supplemental oxygen through a nasal cannula. Desaturation to ≤ 90% was managed by increasing the oxygen flow rate and using an oxygen mask. All three study groups were prescribed 2mg of midazolam and 50µg of fentanyl to reduce anxiety, and 10% lidocaine spray was used as 4 puffs into the vocal cords for local anesthesia. The study was conducted in a double-blind manner, and the patient and the data collector were unaware of the drug grouping of the patients.

To induced sedation, in the first group (k1) ketamine 0.2mg/kg, in the second group (K2) ketamine 0.4mg/kg and in the third group (k3) ketamine 0.5mg/kg was prescribed intravenously (IV).2 minutes later, propofol 1% was administered through a pump syringe containing 15 ml of propofol. First, a bolus dose of 0.4 mg/kg, and then the infusion of propofol was continued at a rate of 50–100 µg/kg/min. Reaching level 4 of sedation based on Ramsey's sedation Score, bronchoscopy was started. If more sedation was needed, 2 ml of 10% propofol was injected as a titration in all three groups. In case of pain during the procedure, in all three groups, 50 µg of fentanyl was used, and in case of pain during recovery, Apotel was used at a dose of 15 mg/kg in 100 ml of normal saline for 10 minutes. At the end, the total amount of propofol consumed was calculated and recorded for each patient.

Outcomes measures

Primary and secondary outcomes were include quality of sedation and its duration, duration of bronchoscopy, patient and bronchoscopist satisfaction, cardiovascular response during bronchoscopy and in recovery room, and side effects during bronchoscopy and in recovery room.

The quality of sedation was evaluated with the Ramsay Sedation Scale, which is a 6-point scale including the following. 1 (anxious and restless), 2 (calm with response to commands), 3 (confused with response to commands), 4 (sleep with response after impact between two eyebrows) and 5 (sleep with slow response to tactile stimuli) and 6 (sleep and no response).

The quality of sedation and its duration, and cardiovascular response were evaluated every 5 minutes during intervention and every 15 minutes during recovery. In recovery after the patients were fully awake, they were asked to express their level of comfort and pain during and after FFB with VAS (Visual Analogue Scale) from 0 (completely comfortable) to 10 (completely uncomfortable) (13).

The length of stay in recovery is determined based on Modified Aldrete Score, and when the patient reaches Aldrete score of 9 or 10, they find the conditions to leave recovery and transfer to the inpatient department (14). The bronchoscopist's satisfaction at the end of the procedure and the patient's satisfaction at the end of the recovery were evaluated according to a 5-point Likert scale including: very dissatisfied, dissatisfied, indifferent, satisfied and completely satisfied (15).

Adverse events during the procedure (Desaturation, hypotension, hypertension, tachycardia, bradycardia, pain...) and during recovery (nausea, vomiting, pain, etc.) were evaluated and recorded.

All data were collected by an observer who was unaware of the grouping.

Randomization and Blinding

The sequence of patient allocation in the studied groups was done by the nurse anesthetist using the random table prepared by the random allocation software. The results of this grouping were kept in sealed opaque envelopes. By opening the envelope, the anesthetized nurse enrolled the patients in three groups of 30 people receiving ketamine (K1, K2 and K3).

In this study, the patient, the anesthesiologist, and the data collector were unaware of the patient's drug grouping. The preparation and administration of drugs were done by an anesthesiologist who had no role in research team.

Sample size:

The required sample size of the study using the sample size formula to compare averages and with a confidence level of 95%, the power of the test is 80%, the standard deviation of the pain intensity is equal to 1.1 (12) and the minimum significant difference between the groups is equal to 0.8 was considered and it was estimated that there were 30 people in each group.

Statistical analysis:

The obtained data were finally entered into SPSS software version 23 (IBM SPSS, Armonk, NY, USA) and with statistical tests of Chi-square, one-way analysis of variance, Mann-Whitney test and analysis of variance with repeated observations, at a significance level of 0.05. >P was analyzed. A 5% alpha error (95% confidence interval) was employed as the threshold for accepting or rejecting the null hypothesis.

In this study, 90 candidates for fiberoptic (flexible) bronchoscopy were randomly divided into three groups of 30 people receiving ketamine in doses of 0.2, 0.4 and 0.5 mg/kg. It was not excluded from study and the analysis was completed on 90 patients (Fig. 1).

There were no significant differences in the results of the three groups in terms of demographic and basic variables (p > 0.05) (Table 1).

Table 1

Analysis of demographic data between three groups.
Variable		Group K1	Group K2	Group K3
Age (yeas) (mean ± SD)	52.5 ± 15.4	53.9 ± 17.5	57 ± 16.7	0.56
Gender (N %) Female	12 (40%)	7 (23.3%)	13 (43.3%)	0.22
Male	18 (60%)	23 (76.7%)	17 (56.7%)	0.22
ASA (N %)) 1	21 (70%)	20 (66.7%)	23 (76.7%)	0.69
2	16 (27.6%)	15 (25.5%)	15 (26.4%)	0.69
Comorbidities (N %))	15 (25.8%)	15 (25.4%)	13 (22.8%)	0.22
	43 (74.2%)	44 (74.6%)	44 (77.2%)

ASA = American Society of Anesthesiologists

In terms of the average score of sedation during the procedure (P < 0.018), duration of sedation (p = 0.001) and length of stay in recovery (p > 0.001) in k3 group was more than K2, and in both groups it was more than k1. Physician satisfaction (p = 0.78) and patient satisfaction (p = 0.019) in k3 group was more than K2, and both groups were more than k1. Average pain during recovery (p = 0.003) in K3 group was less than other groups and no disease had VAS more than 2, so Apotel was not prescribed. Table (2)

Table 2

Variables of sedation, pain, patient and pulmonologist satisfaction and study times between three groups
Variable	Group k1	Group k2	Group k3	Pvalue
Procedure time (minutes)	10(5–15)	10(7–15)	10(5-11.5)	0.16
Sedation time (minutes)	13 ± 3,6	14.5 ± 3.6	16.8 ± 4	0. 01
Sedation score (RSS)	4.47 ± 0.36	4.49 ± 0.28	4.49 ± 0.31	0.018
Recovery time (minutes)	28.8 ± 6.5	35.8 ± 6.3	39 ± 8.3	> 0.001
pain in recovery (VAS)	1.8 ± 0.66	1.50 ± 0.51	1.30 ± 0.47	p = 0.003
Satisfaction of the pulmonologist
Dissatisfied	3(10)	1(3.3)	1(3.3)	0.78
Satisfied	9(30)	10(3.3)	8(26.7)
Completely satisfied	18(60)	19(63.3)	32 (70)
Patient satisfaction
Completely dissatisfied	0(0)	1(3.3)	0(0)	0.019
Dissatisfied	1(3.3)	3(10)	0(0)
Satisfied	8(26.7)	3(10)	1(3.3)
Completely Satisfied	21(70)	23(76.7)	29(96.7)

Evaluation of hemodynamic parameters before, during and after bronchoscopy did not show any significant difference between the three groups in terms of systolic blood pressure, diastolic blood pressure and mean arterial pressure (MAP). In the intra-group study, there was a significant difference in diastolic and MAP in the group receiving 0.5 mg/kg ketamine, but no significant difference was seen in the intra-group study of 0.2 mg/kg ketamine and 0.4 mg/kg ketamine. At the same time, according to the analysis of variance with repeated observations, there was no significant difference between the three groups in the changes in systolic, diastolic and MAP.

Examining the heart rate in the three mentioned groups showed that during and after fiberoptic bronchoscopy, the patients in the K3 group had the highest average heart rate and the K1 group had the lowest average heart rate (P = 0.01). In the intra-group analysis, heart rate changes were significantly different in all three groups. In the intergroup analysis, there was a significant difference in heart rate changes among the three studied groups (P = 0.02).

Examining the percentage of Peripheral capillary oxygen saturation (SpO₂) before, during and after bronchoscopy, no significant difference was observed between the three groups. Also, in the intra-group and inter-group analysis, there was no significant difference in SPO2 changes within the groups and between the groups (Table 3). It should be mentioned that according to the analysis of variance with repeated observations, the variables of age, gender and ASA of the patients had no significant effect on the hemodynamic changes.

Table 3

Mean and standard deviation of hemodynamic parameters before, during and after bronchoscopy between three groups.
Variable / Time	Group k1		Group k3	P*
Systolic Blood Pressure (mmhg)
Before the procedure	125.1 ± 9.2	120.4 ± 14	125.1 ± 9.2	0.26
During the procedure	120.5 ± 13.8	119.3 ± 15.6	127.8 ± 17.8	0.16
Recovery room	122.5 ± 31.8	119.2 ± 15.4	128 ± 19.3	0.69
P**	0.79	0.88	0.35	0.71 ***
Diastolic Blood Pressure (mmhg)
Before the procedure	75 ± 10.3	78.1 ± 9.6	74.8 ± 8.4	0.32
During the procedure	73.1 ± 13	79.3 ± 12.8	83 ± 21.1	0.43
Recovery room	73.1 ± 13	78.6 ± 15	83 ± 8.4	0.081
P**	0.66	0.90	0.015	0.23***
Mean arterial pressure(mmhg)
Before the procedure	91.5 ± 10.3	92.6 ± 9.8	92.2 ± 8.3	0.89
During the procedure	90.3 ± 14.8	94.1 ± 13.8	95.2 ± 13.5	0.36
Recovery room	88.8 ± 13.2	92.5 ± 15.5	99.6 ± 21	0.051
P**	0.51	0.76	0.026	0.207***
Heart Rate
Before the procedure	77.7 ± 7.8	76.5 ± 10.3	80.1 ± 10.7	0.42
During the procedure	82.6 ± 8.7	84.5 ± 11.7	93.2 ± 13.4	0.001
Recovery room	83.8 ± 9.6	85.1 ± 14.9	89.7 ± 13.5	0.19
P**	0.001>	0.001>	0.001>	0.02***
Spo2 (%)
Before the procedure	96.1 ± 1.85	95.77 ± 2.92	96.1 ± 2.21	0.82
During the procedure	96.2 ± 3.35	96.23 ± 1.89	96.23 ± 1.77	0.64
Recovery room	96.86 ± 2.31	95.3 ± 9	96.76 ± 3.75	0.52
P**	0.36	0.83	0.091	0.078***

According to the results, none of the patients suffered from bradycardia during bronchoscopy, but hypertension was observed in 11 patients, hypotension in 16 patients, tachycardia in 19 patients, and decreased peripheral arterial oxygen saturation (Spo2) in 5 patients. According to Table 4, the frequency of hemodynamic disorders There was no significant difference between the three groups (P < 0.05).

Table 4

Frequency distribution of hemodynamic disorders and Adverse events in three groups
Type of disorder	Group k1		Group k3	P*
Hypertension	1 (3.3)	3(10)	7(23.3)	0.072
Hypotension	7 (23.3)	5(16.7)	4(13.3)	0.70
Tachycardia	4 (13.8)	7(23.3)	8(26.7)	0.52
Bradycardia	0 (0)	0(0)	0 (0)	1
O2sat drop	1 (3.3)	3(6.7)	1 (3.3)	0.99
Nausea	1 (3.3)	4(13.3)	3(10)	0.52
Delirium	0 (0)	0 (0)	1 (3.3)	0.99

In terms of postoperative Adverse events, the frequency of nausea in groups K1, K2, and K3 was 1, 4, and 3 (3.3%, 13.3%, and 10%, respectively) (P = 0.52) and there was no case of vomiting in the patients (P < 0.05). ). 1 patient (3.3%) from the ketamine 0.5mg/kg group experienced hallucinations (P = 0.99).

Providing adequate sedation with the least pain during bronchoscopy is an important challenge for anesthesiologists. The present study was conducted with the aim of comparing the effect of three different doses of ketamine on the quality of sedation in fiberoptic (flexible) bronchoscopy.

In this study, 90 candidates for fiberoptic bronchoscopy (flexible) were included in three groups of 30 people receiving ketamine in sub-anesthetic doses (0.2, 0.4 and 0.5 mg/kg) along with propofol. In terms of demographic and basic parameters, the three groups mentioned, the mean Procedure time, satisfaction of the bronchoscopists, average pain in recovery, and length of stay in recovery had no significant difference.

The score of sedation during FFB, duration of sedation and satisfaction of patients in k3 group was higher than K2 group and both groups were more than k1

The average pain during recovery in K3 group was less than K2 group and in both groups less than K1, and no person had VAS more than 2, so Apotel was not prescribed.

In the examination of hemodynamic parameters during the bronchoscopy period and during the recovery period, there was no significant difference between the three groups in terms of changes in systolic and diastole blood pressure and mean arterial blood pressure, as well as changes in the percentage of blood oxygen saturation. According to the results, the average heart rate during the procedure in group K3, the level of K2 was high and the level of k1 was twice as low, in terms of the occurrence of hemodynamic disorders, there was no significant difference between the three groups. In this study, arterial desaturation did not require therapeutic intervention.

It is worth noting that most of the studies conducted so far have investigated the effect of ketamine as a sedative drug for FFB in children and infants. (6, 17, 18). And limited studies have been done on the safety and efficacy of ketamine in adult FFB (3).

In the study of Hwang et al., through a patient-controlled analgesia, they compared the effect of the combination of propofol and alfentanil or propofol and ketamine. As a result, they observed that the combination of ketamine-propofol is superior to alfentanil-propofol. Sympathetic effects of ketamine maintained blood pressure values similar to preoperative levels, and a higher percentage of patients in the ketamine-propofol group reported higher satisfaction and forgetfulness for the bronchoscopy session (19).

In a study of patients undergoing trans bronchial needle aspiration guided by intrabronchial ultrasound (EBUS-TBNA) in four groups of propofol-midazolam (PM group), propofol-ketamine (PK group), propofol-ketamine-midazolam (PKM group) or propofol P group) were included in the study. As a result, the incidence of blood pressure increase was higher in the groups that received ketamine. The combination of PKM required lower doses of these drugs. The recovery time was the shortest in the P group and the longest in the PKM group (20). In a study by Fruchter et al., comparing the effects of ketamine and fentanyl in adult bronchoscopy, this study found ketamine to be as safe and harmless as fentanyl, in addition to the fact that ketamine was associated with less cardiovascular depression and a stronger bronchodilator effect. Therefore, he recommends more use of ketamine during bronchoscopy (3).

In another study, Dal et al. used the combination of ketamine-midazolam and ketamine-propofol during transbronchial needle aspiration guided by intrabronchial ultrasound. As a result, they observed that both combinations provide safe, effective sedation with the satisfaction of patients and bronchoscopists, and there is no superiority between the two compositions (21). In a study, Gunathilaka et al compared sedation with propofol and fentanyl in pediatric bronchoscopy and concluded that for flexible bronchoscopy in children, compared to fentanyl, propofol has shorter induction time, less coughing during the procedure, shorter recovery time and higher doctor satisfaction (22). In previous studies, in terms of recovery time between the group receiving ketamine-propofol and midazolam (KPM) and the group receiving fentanyl propofol midazolam (FPM) (2) and in another study, no difference was reported between the KP and MP groups (21).

In Fruchter's study, there was no statistically significant difference in patient satisfaction between KPM and FPM groups (3), and in another study, patient satisfaction was generally high in KPM, KP, MP and P groups (20). In the present study, increasing the dose of ketamine increased the satisfaction of the patients and the bronchoscopist

In a previous study, in terms of cardiovascular outcomes, mean arterial blood pressure (MAP) in patients receiving ketamine (KPM group) was significantly higher compared to patients receiving fentanyl (FPM group) (2) and the frequency of patients with high blood pressure during the experimental procedure in the patients who received ketamine (KPM and KP) was significantly higher compared to MP.

In terms of the occurrence of hypoxia, in Fruchter's study there was no difference between KPM and FPM groups (3) and in Sazak's study, there was no decrease in arterial oxygen saturation between KPM, KP, MP and P groups (20). The present study is similar to the above studies in terms of the absence of hypoxia.

In a study, Yoon et al compared the effect of propofol alone or propofol together with alfentanil during bronchoscopy, but they did not find any difference in patient satisfaction or cough severity (23).

In the study of Pazoki et al., who compared two doses of 0.3 and 0.5 mg/kg of ketamine with 0.3 mg/kg of pethidine in women undergoing caesarean section, the changes in hemodynamic parameters were not significantly different among the three groups, and the use of ketamine with a higher dose (0.5 mg /kg) has been associated with higher hemodynamic stability (24). In the present study, increasing the dose of ketamine to 0.5 mg/kg, we had good hemodynamic stability

In Yazdi et al.'s study, the addition of 0.25 mg/kg of ketamine to propofol was investigated in patients undergoing cataract surgery. In this study, the average heart rate in two minutes after stimulants was higher in the ketamine group (25). In our study, the 0.5mg/kg group had higher heart rates during surgery.

In the study of Kariman Majed et al., it was concluded that adding ketamine at the rate of 0.5 and 0.75 mg/kg during the induction of anesthesia with propofol along with the improvement of the hemodynamic status in comparison with the groups that received only ketamine or propofol for induction of anesthesia. It was used. (26)

The present investigation is subject to certain limitations that warrant careful consideration. Firstly, the study was conducted on a restricted cohort of participants who underwent flexible fiberoptic bronchoscopy, which constituted the primary focus of this research. Individuals with an ASA class exceeding 2 were excluded from the study. Secondly, the evaluation of sedation levels was devoid of objective measurements, potentially compromising the precision of the findings.

It seems that sedation regimens using ketamine are suitable for adult FFB. Increasing the sub anesthetic dose of ketamine from 0.2 mg/kg to 0.5 mg/kg in combination with propofol is associated with an increase in the Ramsay sedation score, an increase in patient and pulmonologist satisfaction, and a decrease in propofol consumption. Ketamine dose of 0.5 mg/kg can be preferable to other doses for fiberoptic (flexible) bronchoscopy in adults.

ASA =American Society of Anesthesiologists

K: Ketamine

FB: Flexible Bronchoscopy

FFB: Flexible Fiberoptic Bronchoscopy

RSS: Ramsay Sedation Score

VAS: Visual analogue scale

Acknowledgements:

We would like to express our gratitude to the staff of the operating room and the hospital chairman of Faiz for their assistance and participation in the performance of the current study.

Authors' contributions:

H.S. conceptualized the study design. H.S and S.R. developed the study protocols. H.S. drafted the manuscript. H.S. critically revised the manuscript and approved the submission of the final version of the manuscript.

Funding:

Funds were not requested for this study .

Availability of data and materials:

The dataset generated from the current study will be available from the corresponding author upon reasonable request.

Competing interests:

The authors declare that they have no conflict of interest.

Ethics approval and consent to participate: The protocol of this study was approved by the ethics committee of Isfahan University of Medical Sciences under the code " IR.MUI.MED.REC.1399.704 ". Informed consent was obtained from the patients. The study was conducted in accordance with Declaration of Helsinki.

Consent for publication ‘Not applicable’

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Comparison of the effect of three different sub-dissociative doses of ketamine on the quality of sedation in flexible fiber optic bronchoscopy

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