Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300168
• Other study ID #: MISP-51834
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: August 18, 2015
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Procedure:
• Sleeve gastrectomy
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal	Merck Sharp & Dohme Corp.

References & Publications (4)

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. — View 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. — View Citation

Raeder J. Bariatric procedures as day/short stay surgery: is it possible and reasonable? Curr Opin Anaesthesiol. 2007 Dec;20(6):508-12. Review. — View Citation

Servin F. Ambulatory anesthesia for the obese patient. Curr Opin Anaesthesiol. 2006 Dec;19(6):597-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgeon evaluation of working surgical conditions	the surgeon will score the surgical working conditions at 15 min intervals, according to a 5-point ordinal scale	intraoperative