The Effect of General Anesthesia Combined with Transversus Abdominis Plane Block on Postoperative Sleep Disorders in Elderly Patients Undergoing Gastrointestinal Tumor Surgery: A Prospective, Randomized Controlled Trial

doi:10.21203/rs.3.rs-4806447/v1

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The Effect of General Anesthesia Combined with Transversus Abdominis Plane Block on Postoperative Sleep Disorders in Elderly Patients Undergoing Gastrointestinal Tumor Surgery: A Prospective, Randomized Controlled Trial

https://doi.org/10.21203/rs.3.rs-4806447/v1

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Purpose: This study aimed to investigate the effect of general anesthesia combined with transversus abdominis plane block on postoperative sleep disorders in elderly patients undergoing gastrointestinal tumor surgery. Methods: We recruited 94 elderly patients diagnosed with gastrointestinal malignancies, all scheduled for radical laparoscopic surgery. The patients were allocated to two groups using the random number table method: the general anesthesia group (group GA) and the general anesthesia combined with transversus abdominis plane block group (group GT). Group GT got bilateral transversus abdominis plane blocks (TAPB) following the same induction of anesthesia as Group GA, which received the intravenous-inhalation complicated general anesthesia regimen. Wearable devices were utilized to measure sleep on the first day before surgery (P1) as well as the first and third day after surgery (D1 and D3). On P1, D1, and D3 nights, respectively, the Pittsburgh Sleep Quality Index (PSQI) scale was utilized to measure sleepiness and the occurrence of postoperative sleep disorders (POSD). Results: The group GT demonstrated a significant decrease in the usage of remifentanil during surgery (P<0.05) as compared to the group GA. At D1, there was a substantial decrease in the number of awake (P<0.05) and an increase in the ratio of deep sleep to rapid eye movement sleep (REM) in the GT group. The percentage of REM was still rising at D3, and PSQI values at D1 and D3 were considerably lower (P<0.05). Furthermore, there was a decreasing tendency (P<0.05) in the incidence of POSD and the visual analog scores (VAS) at 0.5 and 6 hours after surgical activity in D1. The overall condition, intraoperative state, remedial analgesia, and number of analgesic pump presses did not differ significantly between the two groups (P>0.05). Conclusion: General anesthesia combined with transversus abdominis plane block can improve the postoperative sleep quality of elderly patients with gastrointestinal tumors and reduce the incidence of sleep disorders.

Transversus abdominis plane block

Sleep disorders

Elderly patients

Gastrointestinal tumors

PSQI

Sleep is a physiological phenomenon that is actively produced and regulated by the brain. It is an essential component of human life activities.^1,2 People's sleep patterns change with age, influenced by multiple factors including physical decline, a gradual decrease in the amplitude of circadian oscillations in melatonin levels, and a reduction in the efficiency of the supraoptic nucleus of the hypothalamus. These changes are reflected in the elderly population as a forward shift in the phase of circadian rhythms, an increase in the percentage of time spent in light sleep (N1 and N2), and fragmentation of sleep. Elderly patients may also be predisposed to sleep disorders as a result of opioids, depression, chronic pain, and neurodegenerative changes.^3,4 POSD, a prevalent clinical phenomenon in surgical patients, manifests as abnormal sleep quality or behavioral abnormalities for at least one day following surgery. Its characteristics include frequent nocturnal awakenings, sleep fragmentation, difficulty falling asleep, sleep deprivation, early awakenings, and sleep rhythm disorders.^5,6

TAPB is performed by injecting local anesthetic drugs into the fascial space between the transversus abdominis and the obliquus internus abdominis. This blocks the nerves in the abdominal wall that run in this plane,⁷ providing analgesia in the abdominal wall region, an ideal block and dosing regimen can produce analgesia for 15–20 hours.

Previous research has demonstrated a considerable reduction in intraoperative opioid use and an improvement in patient prognosis when general anesthesia is used in conjunction with TAPB.⁸ However, its effectiveness in improving postoperative sleep quality in elderly patients has yet to be thoroughly investigated. In order to provide a useful reference base for clinical anesthesia, we plan to assess the impact of general anesthesia combined with TAPB on patients' POSD in elderly patients undergoing gastrointestinal cancer surgery.

Ethics

This single-center, prospective, double-blind, randomized controlled trial was formally approved by the Medical Ethics Committee of the Second People's Hospital of Changzhou Affiliated to Nanjing Medical University (No. 2023YLJSA030) and registered prior to patients enrollment in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/index.aspx, 09/01/2023, ChiCTR2300075329, principal investigator: Jie Pu ).

Study Design and Participants

From Septemper 2023 to March 2024, this study covered elderly patients with gastrointestinal malignant tumors scheduled for laparoscopic radical surgery at the Changzhou Second People's Hospital affiliated with Nanjing Medical University, with an age range of 65-80 years old, American Society of Anesthesiologists (ASA) classification Ⅰ to Ⅲ, body mass index (BMI) of 18-30 kg/m². There were no gender restrictions. Patients who met the following criteria were excluded from the study: (1) preoperative PSQI scores higher > 7, (2) sleep apnea syndrome, (3) severe cardiac, cerebral, hepatic, and renal diseases, (4) long-term application of narcotic analgesics or sedatives, (5) patients with a history of psychiatric disorders, such as anxiety and depression. We excluded participants who changed surgical methods, had incomplete follow-up data, withdrew midway, failed or developed complications from TAPB treatment, and were transferred to the ICU after surgery. Written informed consent was obtained from all participants.

Randomization and Blinding

All enrolled patients underwent laparoscopic radical surgery for gastrointestinal malignancies. Two-step screening was used to determine the eligibility of patients, followed by randomization and final enrollment. One day before surgery, initial screening, recruiting, final enrollment, and randomization were completed. Patients were randomized using a computer-generated table of random numbers to either the group GA or the group GT. Group assignments were sealed in opaque envelopes with sequential numbers. Group allocations were unknown to patients, attending surgeons, data collectors, and those doing the final statistical analyses.

Anesthetic and Analgesic Techniques

On regular admission, the following parameters were measured: electrocardiogram (ECG), blood pressure (BP), heart rate (HR), peripheral vascular oxygen saturation (SpO₂), and Bispectral index (BIS). Additionally, oxygen denitrification (at a flow rate of 6 L/min) was given for 3 minutes. After opening the peripheral venous access, 8 ml·kg^-1·h^-1 of crystalloid or colloid fluid was infused intravenously. The patients' intraoperative invasive arterial pressure was then monitored by radial artery puncture catheterization while they were under local anesthetic. Midazolam 0.03 mg/kg, propofol 1.5-2.5 mg/kg, sufentanil 0.3-0.5 μg/kg, and rocuronium bromide 0.6-1.2 mg/kg were injected intravenously to induce anesthesia in the GA group. Following a successful tracheal intubation, mechanical ventilation was started at a 60% oxygen concentration, 6-8 ml/kg tidal volume, and 12-16 times/min. End-expiratory carbon dioxide partial pressure (PETCO₂) was kept between 35 and 45 mmHg (1 mmHg = 0.133 kPa). Propofol and remifentanil were infused via target-controlled infusion and sevoflurane inhalation, with initial effector compartment concentrations of 3 μg/ml and 4 ng/ml, respectively (adjusted intraoperatively based on hemodynamic dynamics and the BIS value). Cisatracurium (0.1 mg·kg^-1·h^-1) was infused intravenously to maintain myorelaxation. Ephedrine 6 mg was injected to raise the blood pressure if the patient's blood pressure decreased more than 20% of the basal value or if the systolic blood pressure was less than 90 mmHg during the procedure; atropine 0.5 mg was delivered to raise the heart rate if it was less than 50 beats per minute.

Following surgery, both groups received patient-controlled intravenous analgesia (PCIA), in which we used a mixture of oxycodone (0.8 mg/kg) and tropisetron (6 mg) diluted to 100 mL with saline.PCIA settings included a background dose of 2 mL/h, a single dose of 2 mL, and a lockout duration of 15 minutes. 75 mg of diclofenac sodium lidocaine was given intramuscularly if remedial analgesia was required.

Intervening Measure

Patients in group GT were placed in a supine position after the anesthesia induction was finished. The probe was then positioned transversely under the raphe to locate the paired rectus abdominis muscle images and white lines. Next, the probe was panned along the ribcage to the midclavicular line, which made the triple structure of the obliquus externus abdominis, obliquus internus abdominis, and Transversus abdominis very evident. Using the in-plane approach, the puncture needle was inserted into the superficial surface of the transversus abdominis muscle below the tendinous membrane of the internal oblique muscle, and after retracting without blood and gas, 30 ml of 0.25% ropivacaine was injected, and the contralateral TAPB was performed in the same way (Figure 1), and no special operation was needed in group GA.

Clinical Data Collection

Intraoperatively, detailed information on fluid input, blood loss, urine output, duration of surgery, duration of anesthesia, consumption of anesthetic drugs, as well as remedial analgesia, and effective number of analgesic pump presses were recorded for 48 hours after the operation. Sleep parameters, such as the percentage of deep sleep, percentage of light sleep, percentage of REM, number of wakefulness, sleep continuity score, and sleep respiratory quality score, were monitored on P1, D1, and D3 nights (8:00 pm to 8:00 am the following day) using a wearable device (wireless smart band Honor 7, Honor Terminal Company Limited.). Subjective sleep quality was measured at P1, D1, and D3 follow-up using the 7-part, 18-entry PSQI⁹ scale. The total score ranged from 0 to 21, with a higher score indicating lower sleep quality. One day before surgery, we used the Hamilton Anxiety Scale (HAMA)¹⁰ and the Depression Screening Scale (PHQ-9)¹¹to check for patients who were not anxious or depressed. The same anesthesiologist responsible for PSQI scoring would record the patient's VAS¹² scores at 0.5h after extubation, and at 6h, 12h, and 24h postoperatively in the activity and rest states.

Observation Outcomes

Primary outcome: the incidence of postoperative sleep disorders in the two groups. Secondary outcomes: PSQI scores of P1, D1, and D3; sleep parameters monitored by P1, D1, and D3 using wearable smart band; the situation of VAS scores in the 24h postoperative period; the number of effective presses of analgesic pumps in the 48h postoperative period, and the situation of remedial analgesia in the ward.

Sample Size

The primary outcome of this study was the incidence of POSD in D1, with the sample size being estimated using PASS 17.0 software. Pre-test results showed that the incidence of POSD in D1 was 30% in the GT group and 64% in the GA group. For a two-sided test, α=0.05 and 1-β=0.9 were chosen, and each group needed to have at least 43 patients. With a 10% dropout rate in mind, each group was expected to have at least 47 individuals signed up.

Statistical Analysis

SPSS software version 26.0 was used for analysis in this study, and P<0.05 was deemed statistically significant. The measurement variables are represented as mean±standard deviation (SD), and countable data are represented by case number or percentage. The t-test of independent samples was used for pairwise comparisons between groups, and the analysis of variance of repeated measurement data was used for intra- and inter-group comparisons at different time points. During data processing, we will eliminate data that are too biased and lack practical significance.

We initially evaluated 102 patients for eligibility to participate in this study, of which 6 patients did not meet the inclusion criteria and 2 patients declined to participate. The remaining 94 patients were enrolled in the study. Subsequently, 1 patient changed the surgical procedure, 1 withdrew midway, 3 were lost to postoperative visits, and 2 were transferred to the ICU; a total of 7 cases were excluded. Finally, 87 cases were included in the statistical analysis, 44 cases in the group GA and 43 cases in the group GT (Figure 2).

There were no significant differences between the two groups in terms of gender, age, BMI, preoperative anxiety and depression assessment, and type of surgery (P>0.05), as shown in Table 1. The safety of the TAPB was guaranteed because we did not find any documentation of any negative reactions in the group GT, including but not limited to infection, hematoma development, nerve injury, and local anesthetic toxicity.

The group GT used considerably less remifentanil during the procedure than group GA (P<0.05). The duration of surgery, duration of anesthesia, the dosages of propofol, sufentanil, and ephedrine, as well as fluid input, blood loss, urine output, effective number of analgesic pump presses, and the requirement for remedial analgesics, did not significantly differ between the two groups (P>0.05) (Table 2).

In terms of sleep parameters captured by the wearable smart band, group GT experienced a higher percentage of both deep sleep and REM sleep in D1 (P<0.05) compared to the group GA, and and a lower number of wakefulness (P<0.05). In D3, the proportion of REM was still higher in group GT (P<0.05). There was no significant difference between the two groups in each sleep parameter of P1 (P>0.05)(Figure 3).

Table 1 Patient Baseline Profile Characteristics

Characteristic	Group GA(n=44)	Group GT(n=43)	P value
Gender, M/F	20/24	17/26	0.475
Age, mean±SD, y	70.91±3.69	70.49±3.61	0.572
BMI, mean±SD, kg/m²	23.24±2.12	23.82±1.35	0.137
Anxiety scores, mean±SD, score	3.09±1.36	3.00±1.00	0.724
Depression scores, mean±SD, score	1.36±1.12	1.56±0.98	0.393
Type of surgery, n(%)			0.460
Radical surgery for gastric tumors	21(47.73)	18(41.86)
Radical surgery for intestinal tumors	23(52.27)	25(58.14)

Abbreviations: BMI, body mass index

The patient's perioperative PSQI score and incidence of POSD were assessed by a specialized anesthesiologist. Compared with the group GA, the group GT showed a significant decrease in D1 and D3 PSQI scores (P<0.05) and a decrease in the incidence of D1 POSD (P<0.05). There was no significant difference between the two groups in P1 PSQI scores and the incidence of D3 POSD (P>0.05) (Table 3).

Comparing the VAS scores of the two groups at each time point during the 24-hour postoperative period, it was discovered that group GT had lower activity VAS scores at 0.5h and 6h after surgery(P<0.05). At other time points, no significant difference was found between the activity and rest VAS scores (P>0.05) (Figure 4).

Table 2 Patient Perioperative Data Characteristics

Characteristic	Group GA(n=44)	Group GT(n=43)	P value
Duration of surgery, mean±SD, min	170.34±16.08	174.30±17.10	0.269
Duration of anesthesia, mean±SD, min	199.77±21.02	200.12±16.57	0.933
Consumption of anesthetic drugs, mean±SD, mg
Propofol	470.91±55.11	476.63±45.51	0.600
Remifentanil	1.02±0.13	0.94±0.10	0.001
Sufentanil	41.59±4.91	42.26±4.05	0.493
Ephedrine	10.16±5.94	9.70±4.58	0.686
Intraoperative fluid input volume, mean±SD, ml	1902.95±228.98	1867.67±181.74	0.429
Intraoperative blood loss, mean±SD, ml	103.64±13.22	99.42±9.95	0.097
Urine output, mean±SD, ml	592.95±72.96	576.28±68.35	0.275
Effective number of analgesic pump presses, mean±SD, times	1.68±1.25	1.40±0.88	0.221
Postoperative remedial analgesia, n（%）	15(34.09)	8(18.60)	0.102

Table 3：Patient PSQI Scores and Incidence of POSD
	PSQI, mean±SD, score			POSD, n（%）
	P1	D1	D3	P1	D1	D3
Group GA(n=44)	4.43±1.021	7.77±1.395	6.02±1.229	—	26（59.09）	10（22.73）
Group GT(n=43)	4.37±0.976	6.26±1.498	4.88±1.349	—	13（30.23）	5（11.63）
P value	0.781	<0.001*	<0.001*	—	0.002*	0.067

Abbreviations: PSQI, Pittsburgh Sleep Quality Index; POSD, postoperative sleep disorders; P1, first day before surgery; D1, first day after surgery; D3, third day after surgery.

*P<0.05 versus the Group GA

Normal human physiological sleep is divided into non-rapid eye movement (NREM) and REM, and the NREM and REM cycles are repeated 4-6 times per night, each lasting 90-100 minutes. REM makes up 20%–25% of the overall amount of sleep, whereas NREM is separated into three stages, N1, N2, and N3, which represent 2%–5%, 45%–55%, and 15%–20% of the total sleep period, respectively.¹³^,¹⁴High-quality sleep is essential for maintaining normal physical and mental health, and the prevalence of POSD is high in patients undergoing major surgery and in elderly patients.¹⁵ POSD can weaken the immune system, increase the risk of cardiovascular disease, and interfere with postoperative recovery, leading to anxiety, depression, postoperative delirium, or prolonged cognitive decompensation.¹⁶^,¹⁷ Studies have indicated that intraoperative opioids, as well as postoperative pain, can lead to decreased sleep quality after falling asleep, such as shorter sleep duration, reduced sleep efficiency, and reduced sleep depth.¹⁸Furthermore, studies have demonstrated that sleep deprivation can lower pain thresholds and increase a patient's sensitivity to pain, and that POSD may improve a patient's perception of pain by altering pain modulation pathways.¹⁹^,²⁰Patients in our study had intraoperative bilateral TAPB performed before laparoscopic radical surgery for gastrointestinal malignant tumors. The PSQI scale and a wearable smart band were used to carefully assess the patients' preoperative and postoperative sleep. We found that TAPB can improve POSD, reduce the use of opioids, improve patients' comfort, and have important clinical value in pain management in gastrointestinal oncologic surgery.

Although polysomnography is widely used for sleep monitoring and is the gold standard for diagnosing sleep-related illnesses, but its complexity, accessibility, and impact on subject comfort are all shackles to its further development and application. Research has demonstrated that wearable smart band can measure sleep and activity levels objectively, is user-friendly, and that they can monitor postoperative sleep in real-time and objectively, which can satisfy clinical sleep monitoring requirements.²¹ The smart band used in this study is based on the TruSleepTM sleep monitoring algorithm (TruSeenTM 2.0) with heart rate and motion sensors, which is validated by the University of Bern in Switzerland. With high-precision monitoring capability, it can accurately differentiate between deep sleep, light sleep, REM, and awakening states, and its accuracy is as high as 96.3% when benchmarked against professional polysomnography monitors. The subjective evaluation of sleep using the PSQI scale is justified because, with a score of 7, the sensitivity and specificity of identifying sleep disorders were 98.3% and 90.2%, respectively (Kappa=0.89, P<0.01)²². Therefore, in this study, we used the PSQI scale and wearable smart band to comprehensively assess the sleep of elderly patients undergoing surgery for gastrointestinal tumors from both subjective and objective aspects.

According to the study's findings, the group GT experienced a significantly lower incidence of POSD at D1, a higher proportion of deep sleep and REM, fewer wakefulness episodes at D1, a higher proportion of REM at D3, and lower PSQI scores at D1 and D3. These findings also suggest that general anesthesia combined with TAPB can effectively improve POSD in elderly patients undergoing surgery for gastrointestinal tumors. In the present study, we demonstrated that group GT used significantly less intraoperative remifentanil than group GA. This is likely due to the fact that TAPB provided additional intraoperative analgesia, which decreased patients' perception of intraoperative pain and, as a result, their need for opioids. One previous study demonstrated that²³ normally, adenosine levels peak during sleep and promote sleep, and that opioids may impair sleep by reducing the pontine reticular formation of the basal forebrain and the anaphase region of the anterior cerebral plexus. This is because opioids either block the release of adenosine or promote its degradation. Previous studies have demonstrated that opioids influence sleep via μ-opioid receptors on GABAergic neurons in the ventrolateral prefrontal cortex (VLPO). Opioids also hyperpolarize the membrane potential in the VLPO in isolated brain slices, which prevents these sleep-promoting neurons from discharging.²⁴^,²⁵Consistent with the results of this study, another researcher showed that patients receiving intraoperative remifentanil had substantially worse sleep quality, with a 72.3% drop in REM sleep time.²⁶Thus, this study raises the possibility that the improvement in POSD in elderly patients having gastrointestinal oncologic surgery that results from the combination of general anesthesia and TAPB may be due to a decrease in the usage of remifentanil during the procedure.

Furthermore, in this study, activity VAS scores at 0.5h and 6h after surgery were significantly lower in group GT than in group GA. Numerous studies found that pain patients experienced longer delays in falling asleep, woke up more frequently during the night, and had a shorter duration of sleep, lower sleep efficiency, and less deep sleep;²⁷^,²⁸ Previous studies have confirmed that patients with pain spent more time in the first stage of sleep and experienced more sleep fragmentation. This altered their NREM sleep, REM sleep, and wakefulness periods, as well as affecting delta wave power during NREM sleep.²⁹^,³⁰ Therefore, it can be speculated in this study that the ameliorative effect of TAPB on POSD may also be related to postoperative pain relief in patients.

The present study is subject to certain limitations. Firstly, the study's sample only consisted of patients who were between the ages of 65 and 80. Secondly, the study's postoperative follow-up period was only 3 days, which may not accurately reflect the long-term effects and complication rates. Extending the follow-up period could be more beneficial in evaluating the long-term effects of general anesthesia combined with TAPB on patients with sleep disorders; Furthermore, the accuracy and dependability of the results may be impacted by this study's inadequate control for other variables that may affect sleep quality, such as the use of postoperative medication, postoperative complications, noise, light, and turnover in the ward at night.

In conclusion, general anesthesia combined with transversus abdominis plane block can improve the postoperative sleep quality of elderly patients with gastrointestinal tumors and reduce the incidence of sleep disorders.

Data Sharing Statement

Data supporting the results of this study are available from the corresponding author (Yimin Hu) upon request.

Funding

This study was supported by the Changzhou Municipal Health Commission Science and Technology Project Establishment Project (Major Project) (ZD202315).

Disclosure

The authors report no conflicts of interest in this work.

Author Contribution

Yimin Hu : This author helped study design; Jie Pu : This author helped manuscript writing; Yue Xiao and Yanan Cao: This author helped clinical anaesthesia management; Zhenhua Liu: This author helped data collecting and analysis; Chendong Guo: This author helped data collecting and analysis; Yuzhong Jin: This author helped patient recruitment and operative procedures.

Acknowledgments

The authors would like to thank the Second People's Hospital of Changzhou City affiliated with Nanjing Medical University for supporting this study. We would also like to thank the gastrointestinal surgeons for their support of this study.

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The Effect of General Anesthesia Combined with Transversus Abdominis Plane Block on Postoperative Sleep Disorders in Elderly Patients Undergoing Gastrointestinal Tumor Surgery: A Prospective, Randomized Controlled Trial

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