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Completed

NCT Number: NCT02300168

Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleeve gastrectomy

Procedure

Laparoscopic sleeve gastrectomy (LSG) is a restrictive procedure which consists in creating a narrow tube-like stomach, designed to decrease appetite by reducing the ability of the stomach to distend.

Primary outcomes

  1. surgeon evaluation of working surgical conditions

    Time frame: intraoperative

    the surgeon will score the surgical working conditions at 15 min intervals, according to a 5-point ordinal scale

Sponsors and collaborators

Lead sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Neuromuscular Blockade as a Determinant of Surgical Outcome and Post-operative Recovery, in Patients Undergoing Elective Laparoscopic Bariatric Surgery

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2014
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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