Dataset Information

Effects of depth of neuromuscular block on surgical operating conditions in women undergoing gynecologic laparoscopic surgery: a randomized clinical trial.

ABSTRACT:

Background

In recent years, the relationship between the advantages and disadvantages of a deep neuromuscular block (DNMB), compared to a moderate block (MNMB) in laparoscopic surgery, has been increasingly studied.

Objective

Evaluate the effect of D-NMB compared to M-NMB in gynecological laparoscopic surgery.

Methods

This was a parallel-group, double-blind, randomized clinical trial, conducted at a single center in Italy between February 2020 and July 2020. American Society of Anesthesiologist (ASA) I-II risk class patients scheduled for elective gynecological laparoscopic surgery were randomized into a 1:1 ratio to either experimental or control group. The first one included DNMB with a rocuronium bolus at the starting dose of 1.2 mg/kg and a maintenance dose (0.3-0.6 mg/kg/h). The second one included MNMB with a rocuronium bolus at the starting dose of 0.6 mg/kg, and a maintenance dose in boluses (0.15-0.25 mg/kg). The primary outcome was the intraoperative surgical condition assessed every 15 min by the surgeon as a 5-point scale. The secondary outcome was the time needed to discharge patients from post-anesthesia care unit (PACU). The tertiary outcome was the assessment of the intra-operative hemodynamic instability. A sample size of 50 patients was planned.

Results

One hundred five patients were assessed for eligibility, 55 were excluded. Fifty patients met the inclusion criteria and were enrolled. The average score for the operative field was 4 for the D-NMB group and 3 for the M-NMB group (p value < 0.01). The length of stay in PACU was 13 min for the DNMB group and 22 min for the MNMB group (p value = 0.02).

Conclusions

Deep neuromuscular block improves intraoperative surgical condition during gynecological laparoscopic surgery.

Trial registration

clinicalTrials.gov NCT03441828.

SUBMITTER: Coviello A

PROVIDER: S-EPMC10245408 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Effects of depth of neuromuscular block on surgical operating conditions in women undergoing gynecologic laparoscopic surgery: a randomized clinical trial.

Coviello Antonio A Ianniello Marilena M Buonanno Pasquale P Di Falco Nausica N Iacovazzo Carmine C Maresca Alfredo A Vargas Maria M Marra Annachiara A Candice Agostino A Saccone Gabriele G Zullo Fulvio F Servillo Giuseppe G

Journal of anesthesia, analgesia and critical care 20230119 1

<h4>Background</h4>In recent years, the relationship between the advantages and disadvantages of a deep neuromuscular block (DNMB), compared to a moderate block (MNMB) in laparoscopic surgery, has been increasingly studied.<h4>Objective</h4>Evaluate the effect of D-NMB compared to M-NMB in gynecological laparoscopic surgery.<h4>Methods</h4>This was a parallel-group, double-blind, randomized clinical trial, conducted at a single center in Italy between February 2020 and July 2020. American Societ ...[more]

PMID: 37386582

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Project description:BackgroundSurgical conditions in laparoscopic surgery are largely determined by the depth of neuromuscular relaxation. Especially in procedures that are confined to a narrow working field, such as retroperitoneal laparoscopic surgery, deep neuromuscular relaxation may be beneficial. Until recently, though, deep neuromuscular block (NMB) came at the expense of a variety of issues that conflicted with its use. However, with the introduction of sugammadex, rapid reversal of a deep NMB is feasible. In the current protocol, the association between the depth of NMB and rating of surgical conditions by the surgeon and anesthesiologist is studied.Methods/designThis is a single-center, prospective, randomized, blinded, parallel group and controlled trial. Eligible patients are randomly assigned to one of two groups: (1) deep NMB (post-tetanic count, one or two twitches; n = 12) and (2) moderate NMB (train-of-four, 1 to 2 twitches, n = 12) by administration of high-dose rocuronium in Group 1 and a combination of atracurium and mivacurium in Group 2. The NMB in Group 1 is reversed by 4 mg/kg sugammadex; the NMB in Group 2 by 1 mg neostigmine and 0.5 mg atropine. Patients are eligible if they are over 18 years, willing to sign the informed consent form, and are scheduled to undergo an elective laparoscopic renal procedure or laparoscopic prostatectomy. A single surgeon performs the surgeries and rates the surgical conditions on a five-point surgical rating scale (SRS) ranging from 1 (poor surgical conditions) to 5 (excellent surgical conditions). The intra-abdominal part of the surgeries is captured on video and a group of five anesthesiologists and ten surgical experts will rate the videos using the same SRS. The primary analysis will be an intention-to-treat analysis. Evaluation will include the association between the level of NMB and SRS, as obtained by the surgeon performing the procedure and the agreement between the scoring of the images by anesthesiologists and surgeons.DiscussionWe aim to show that under the right conditions the perceived opposing goals of surgeons and anesthesiologists (optimal surgical conditions vs. optimal postoperative conditions) may be met without compromise to either.Trial registrationClinicalTrials.gov identifier NCT01631149.

Project description:BackgroundPatients with diabetes mellitus are at a high risk of developing postoperative acute kidney injury. For patients receiving laparoscopic surgery, standard-pressure pneumoperitoneum (SPP) currently applied in clinical practice also undermines renal perfusion. Several studies have shown that low-pressure pneumoperitoneum (LPP) might reduce pressure-related ischemic renal injury. However, LPP may compromise the view of the surgical field. Previous studies have indicated that deep neuromuscular blockade (NMB) can ameliorate this issue. However, the conclusion is still uncertain. The hypothesis of this study is that the joint use of LPP and deep NMB can reduce perioperative renal injury in diabetic patients undergoing laparoscopic pelvic surgery without impeding the view of the surgical field.MethodsThis is a double-blinded, randomized controlled trial using a 2 × 2 factorial trial design. A total of 648 diabetes patients scheduled for major laparoscopic pelvic surgeries at Peking Union Medical College Hospital will be randomized into the following four groups: SPP (12-15 mmHg) + deep-NMB (post-tetanic count of 1-2) group, LPP (7-10 mmHg) + deep-NMB group, SPP + moderate-NMB (train-of-four of 1-2) group, and LPP + moderate-NMB group. The primary outcome is serum cystatin C level measured before insufflation, after deflation, 24 h postoperatively, and 72 h postoperatively. The secondary outcomes are serum creatinine level, intraoperative urine output, erythrocytes in urinary sediment, renal tissue oxygen saturation, Leiden's surgical condition rating scale, surgery duration, and occurrence of bucking or body movement.DiscussionThis study will provide evidence for the effect of LPP on renal function protection in patients with diabetes undergoing laparoscopic pelvic surgery. The trial can also help us to understand whether deep NMB can improve surgical conditions.Trial registrationClinicalTrials.gov : NCT04259112 . Prospectively registered on 5 February 2020.

Dataset Information

Effects of depth of neuromuscular block on surgical operating conditions in women undergoing gynecologic laparoscopic surgery: a randomized clinical trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

Effects of depth of neuromuscular block on surgical operating conditions in women undergoing gynecologic laparoscopic surgery: a randomized clinical trial.

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