Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery

Completed

• Conditions: Bariatric Surgery Candidate

• Registration Number: NCT02300168
• Lead Sponsor: Hopital du Sacre-Coeur de Montreal

Brief Summary

The aim of the current observational study is to better assess the relationships between neuromuscular blockade and multiple surgical outcomes in patients undergoing elective laparoscopic bariatric surgery.

Detailed Description

Performing bariatric surgery as a short-stay procedure is an ongoing trend in many centers around the world. For morbidly obese (MO) patients, the anesthetic approach is based on choosing drugs that have the least potential for accumulation. This allows a more rapid and clear-headed recovery and contributes to reduced duration of perioperative time. However, when neuromuscular blockade (NMB) is required during surgery, complete recovery is a major factor that may prevent from a rapid fast-track discharge.

In Canada, reversal of NMB is achieved by using acetylcholinesterase (AChE) inhibitors, mostly neostigmine, which must be administered after a certain level of spontaneous recovery in order to ensure a complete reversal. This elongates the time spent in the operating room (OR), and prevent therefore from a fast track surgery procedure. On the other hand, in an effort to shorten the time spent in the OR, AChE inhibitors may sometime be administered too early before spontaneous recovery, and post-operative residual curarization (PORC) may then be observed. In the post-anesthesia care unit (PACU), PORC may be particularly problematic, because of the possible occurrence of critical respiratory events (CREs). This in turn is also associated with significant delayed discharges.

Because of the aforementioned inconveniences, Canadian anesthesiologists are reluctant to induce deep NMB. Consequently, intra-abdominal pressure remain non optimal during the surgery, which do not facilitate the surgeons work, in addition to increase perioperative time. This problem is particularly frequent in cases of bariatric surgeries.

The current study will explore this question from the perspective of the surgeon satisfaction and the patient quality of recovery.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2014-11
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-24
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

MO patients [body mass index (BMI)≤ 55kg/m2] scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.

Exclusion Criteria

• a physical status >3 (ASA),
• a difficult tracheal intubation,
• a known or suspected disorder affecting NMB,
• a renal, pulmonary, cardiac, and/or hepatic dysfunction,
• malignant hyperthermia,
• pregnancy, breastfeeding,
• allergy or contraindication to narcotics, rocuronium, neostigmine, or other medications used during anesthesia
• patients with sleep apnea syndrome will also be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
surgeon evaluation of working surgical conditions	intraoperative	the surgeon will score the surgical working conditions at 15 min intervals, according to a 5-point ordinal scale