Dataset Information

Application of opioid-free general anesthesia for gynecological laparoscopic surgery under ERAS protocol: a non-inferiority randomized controlled trial.

ABSTRACT:

Background

Enhanced recovery after surgery (ERAS) is now widely used in various surgical fields including gynecological laparoscopic surgery, but the advantages of opioid-free anesthesia (OFA) in gynecological laparoscopic surgery under ERAS protocol are inexact.

Aims

This study aims to assess the effectiveness and feasibility of OFA technique versus traditional opioid-based anesthesia (OA) technique in gynecological laparoscopic surgery under ERAS.

Methods

Adult female patients aged 18 ~ 65 years old undergoing gynecological laparoscopic surgery were randomly divided into OFA group (Group OFA, n = 39) with esketamine and dexmedetomidine or OA group (Group OA, n = 38) with sufentanil and remifentanil. All patients adopted ERAS protocol. The primary outcome was the area under the curve (AUC) of Visual Analogue Scale (VAS) scores (AUC_VAS) postoperatively. Secondary outcomes included intraoperative hemodynamic variables, awakening and orientation recovery times, number of postoperative rescue analgesia required, incidence of postoperative nausea and vomiting (PONV) and Pittsburgh Sleep Quality Index (PSQI) perioperatively.

Results

AUC_VAS was (Group OFA, 16.72 ± 2.50) vs (Group OA, 15.99 ± 2.72) (p = 0.223). No difference was found in the number of rescue analgesia required (p = 0.352). There were no between-group differences in mean arterial pressure (MAP) and heart rate (HR) (p = 0.211 and 0.659, respectively) except MAP at time of surgical incision immediately [(Group OFA, 84.38 ± 11.08) vs. (Group OA, 79.00 ± 8.92), p = 0.022]. Times of awakening and orientation recovery in group OFA (14.54 ± 4.22 and 20.69 ± 4.92, respectively) were both longer than which in group OA (12.63 ± 3.59 and 18.45 ± 4.08, respectively) (p = 0.036 and 0.033, respectively). The incidence of PONV in group OFA (10.1%) was lower than that in group OA (28.9%) significantly (p = 0.027). The postoperative PSQI was lower than the preoperative one in group OFA (p = 0.013).

Conclusion

In gynecological laparoscopic surgery under ERAS protocol, OFA technique is non-inferior to OA technique in analgesic effect and intraoperative anesthesia stability. Although awakening and orientation recovery times were prolonged compared to OA, OFA had lower incidence of PONV and improved postoperative sleep quality.

Trial registration

ChiCTR2100052761, 05/11/2021.

SUBMITTER: Chen L

PROVIDER: S-EPMC9881250 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Application of opioid-free general anesthesia for gynecological laparoscopic surgery under ERAS protocol: a non-inferiority randomized controlled trial.

Chen Liang L He Wensheng W Liu Xue X Lv Fahui F Li Yuanhai Y

BMC anesthesiology 20230127 1

<h4>Background</h4>Enhanced recovery after surgery (ERAS) is now widely used in various surgical fields including gynecological laparoscopic surgery, but the advantages of opioid-free anesthesia (OFA) in gynecological laparoscopic surgery under ERAS protocol are inexact.<h4>Aims</h4>This study aims to assess the effectiveness and feasibility of OFA technique versus traditional opioid-based anesthesia (OA) technique in gynecological laparoscopic surgery under ERAS.<h4>Methods</h4>Adult female pat ...[more]

PMID: 36707777

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Project description:Sleep disorder dramatically affects people's physical and mental health. Here, we investigated the effect of preoperative sleep disorders on anesthesia recovery and postoperative pain in patients undergoing laparoscopic gynecological surgery under general anesthesia. 120 patients who underwent elective laparoscopic gynecological surgery under general anesthesia in Taizhou Central Hospital from November 2021 to March 2022 were included. According to the score of the Pittsburgh sleep quality index (PSQI), the participating patients were divided into four groups: control group (control group), mild sleep disorder group A (group A), moderate sleep disorder group B (group B), and severe sleep disorder group C (group C), with 30 patients in each group. The changes of mean arterial pressure (MAP) and heart rate (HR) at different time points, operation time, anesthesia time, extubation time, the time when Aldrete score reached 10 points, visual analog score (VAS) serum interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-α (TNF-α) were compared among different groups. Our study demonstrated that there were no significant differences in MAP and HR among the four groups at the same time points (all P > 0.05). Significant differences in the time of extubation and Aldrete score reaching 10 points had been found among the four groups (all P < 0.001), indicating more sleep disorder induced longer extubation and recovery time. There were significant differences in VAS scores among the four groups at both different and the same time points (all P < 0.001), suggesting more sleep disorders induced more pain in the sufferers. Serum IL-6 levels were significantly higher in the three sleep disorder groups than the control group at 6 h and 24 h after the operation (all P < 0.05), while group C has the highest IL-6 levels as compared to the other group (P = 0.09 and P < 0.001, respectively). At 6 h after operation, serum levels of TNF-α in group C were significantly higher than in the control group (P = 0.044), but no significant differences were found in the other two groups (all P > 0.05). Positive correlation with preoperative PSQI score has been found with the times of extubation, the time of Aldrete score reaching 10 points, the VAS at 1 h, 6 h, and 24 h after operation, the level of serum IL-6 at 1 day before operation and 6 h and 24 h after operation, and the TNF-α at 6 h and 24 h after operation (all P < 0.001). The present study showed that the degree of preoperative sleep disorders could affect the quality of postoperative awakening and pain of patients undergoing laparoscopic gynecological surgery under general anesthesia, which might be associated with the aggravation of inflammatory reactions in the body.

Project description:IntroductionThere is scarce data on the safety and efficacy of opioid-free anesthesia (OFA), in resource-limited settings due to the non-availability of dexmedetomidine, the reference OFA agent. We aimed to demonstrate the feasibility, efficacy and safety of a practical OFA protocol not containing dexmedetomidine, adapted for low-resource environments in very painful surgeries like gynecological surgery.MethodsWe conducted a randomized pilot study on ASA I and II women undergoing elective gynecological surgery at a tertiary care hospital in Cameroon. Patients were matched in a ratio of 1:1 into an OFA and a conventional general anesthesia (CGA) group. The OFA protocol entailed the intravenous (IV) magnesium sulfate, lidocaine, ketamine, dexamethasone, propofol, and rocuronium, followed by isoflurane and a continuous infusion of a calibrated mixture of magnesium sulfate, ketamine and clonidine. The CGA protocol was IV dexamethasone, diazepam, fentanyl, propofol, and rocuronium, followed by isoflurane and reinjections of fentanyl propofol and a continuous infusion of normal saline as placebo. The primary endpoints were the success rate of OFA, isoflurane consumption and intraoperative anesthetic complications. The secondary endpoints were postoperative pain intensity, postoperative complications, patient satisfaction assessed using the QoR-40 questionnaire and the financial cost of anesthesia.ResultsWe enrolled a total of 36 women undergoing gynecological surgery; 18 in the OFA group and 18 in the CGA group. The success rate of OFA was 100% with significant lesser consumption of isoflurane in the OFA group, no significant intraoperative complication and better intraoperative hemodynamic stability in the OFA group. Postoperatively, compared to the CGA group, the OFA group had statistically significantly less pain during the first 24 h, no morphine consumption for pain relief, had less hypoxemia during the first six hours, less paralytic ileus, less nausea and vomiting, no pruritus and better satisfaction. The mean financial cost of this adapted OFA protocol was statistically significant lesser than that of CGA.ConclusionThis OFA regimen without dexmedetomidine for a low-resource setting has a promising success rate with few perioperative complications including mild intraoperative hemodynamic changes, decrease postoperative complications, pain, and opioid consumption in patients undergoing elective gynecology surgery.Trial registrationThis study was registered at clinicaltrials.gov on 03/02/2021 under the registration number NCT04737473.

Project description:Since the advantages of robotic surgery and laparoscopic surgery in the number of lymph node resections are not well understood, this meta-analysis used evidence-based medicine to assess the difference in the number of lymph nodes retrieved in gynecological cancer between the two surgical methods to guide clinical treatment. In the present meta-analysis, the Pubmed, Embase, Cochrane, China National Knowledge Infrastructure and Wanfang libraries were searched for articles that were published from the time of the database's inception to January 2021, including cohort studies and randomized controlled trials, where the observation group underwent robotic surgery to treat gynecological cancers and the control group underwent laparoscopic surgery to treat gynecological cancers, including cervical and ovarian cancers and endometrial cancers. Duplicate publications, studies with no full text, incomplete information or where the authors were unable to perform data extraction, animal experiments, reviews and systematic reviews were excluded. STATA 15.1 was used to analyze the data. Robotic surgery resulted in a significant increase in the number of lymph nodes retrieved from the pelvis [standard mean difference (SMD)=0.24; 95% CI, 0.04-0.45; P=0.007] and para-aortic (SMD=0.41; 95% CI, 0.13-0.69; P=0.004) regions compared with the number retrieved by laparoscopic surgery. Furthermore, there was no significant difference in operating time between robotic and laparoscopic surgery, despite the use of different instruments (SMD=0.12; 95% CI, -0.35-0.58; P=0.616). The amount of blood lost during robotic surgery was significantly less compared with that lost during laparoscopic surgery [SMD=-0.40; 95% CI, -0.58-(-0.22); P<0.001]. The present study evaluated cancer recurrence and death in further detail, and no statistically significant difference was demonstrated between robotic surgery and laparoscopic surgery in terms of recurrence rate [odds ratio (OR)=0.59; 95% CI, 0.21-1.65; P=0.318] and mortality rate (OR=0.31; 95% CI, 0.08-1.30; P=0.109). The present study demonstrated that robotic surgery was able to retrieve more pelvic and para-aortic lymph nodes than traditional laparoscopic surgery, which was consistent with previous reports. With regards to blood loss, The difference in operation time between the two surgical methods was not statistically significant, whereas the estimated blood loss of robotic surgery was significantly lower than that of traditional laparoscopic surgery. There was no statistically significant difference in the recurrence rate and mortality rate of the two surgical modality.

Project description:BackgroundReducing intra-operative opioid consumption benefits patients by decreasing postoperative opioid-related adverse events. We assessed whether opioid-free anesthesia would provide effective analgesia-antinociception monitored by analgesia index in video-assisted thoracoscopic surgery.MethodsPatients (ASA Ⅰ-Ⅱ, 18-65 years old, BMI <30 kg m-2) scheduled to undergo video-assisted thoracoscopic surgery under general anesthesia were randomly allocated into two groups to receive opioid-free anesthesia (group OFA) with dexmedetomidine, sevoflurane plus thoracic paravertebral blockade or opioid-based anesthesia (group OA) with remifentanil, sevoflurane, and thoracic paravertebral blockade. The primary outcome variable was pain intensity during the operation, assessed by the depth of analgesia using the pain threshold index with the multifunction combination monitor HXD‑I. Secondary outcomes included depth of sedation monitoring by wavelet index and blood glucose concentration achieved from blood gas.ResultsOne hundred patients were randomized; 3 patients were excluded due to discontinued intervention and 97 included in the final analysis. Intraoperative pain threshold index readings were not significantly different between group OFA and group OA from arriving operation room to extubation (P = 0.86), while the brain wavelet index readings in group OFA were notably lower than those in group OA from before general anesthesia induction to recovery of double lungs ventilation (P <0.001). After beginning of operation, the blood glucose levels in group OFA increased compared with baseline blood glucose values (P < 0.001). The recovery time and extubation time in group OFA were significantly longer than those in group OA (P <0.007).ConclusionsThis study suggested that our OFA regimen achieved equally effective intraoperative pain threshold index compared to OA in video-assisted thoracoscopic surgery. Depth of sedation was significantly deeper and blood glucose levels were higher with OFA. Study's limitations and strict inclusion criteria may limit the external validity of the study, suggesting the need of further randomized trials on the topic. Trial registration: ChiCTR1800019479, Title: "Opioid-free anesthesia in video-assisted thoracoscopic surgery lobectomy".

Dataset Information

Application of opioid-free general anesthesia for gynecological laparoscopic surgery under ERAS protocol: a non-inferiority randomized controlled trial.

Background

Aims

Methods

Results

Conclusion

Trial registration

Publications

Application of opioid-free general anesthesia for gynecological laparoscopic surgery under ERAS protocol: a non-inferiority randomized controlled trial.

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