Clinical trial NCT02300168: Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery
Official title: Neuromuscular Blockade as a Determinant of Surgical Outcome and Post-operative Recovery, in Patients Undergoing Elective Laparoscopic Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Keywords: bariatric surgery; neuromuscular blockade
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MO patients from the bariatric surgery department of Hopital 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.

Eligibility criteria: 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.

Primary outcomes:
measure: surgeon evaluation of working surgical conditions
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hopital Sacre Coeur de Montreal
name: Pierre Y Garneau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raeder J. Bariatric procedures as day/short stay surgery: is it possible and reasonable? Curr Opin Anaesthesiol. 2007 Dec;20(6):508-12. doi: 10.1097/ACO.0b013e3282f09443.
citation: Servin F. Ambulatory anesthesia for the obese patient. Curr Opin Anaesthesiol. 2006 Dec;19(6):597-9. doi: 10.1097/ACO.0b013e328010cb78.
citation: Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
citation: Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U. Postoperative residual curarization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010 Sep;105(3):304-9. doi: 10.1093/bja/aeq157. Epub 2010 Jun 24.