Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery

NCT02300168 | Completed DMC

• 1 other identifier: MISP-51834
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bariatric Surgery Candidate

Keywords

bariatric surgery; neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MO patients from the bariatric surgery department of Hopital Sacre Coeur de Montreal

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (4)

• 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.

  PMID: 17989541 RESULT

• Servin F. Ambulatory anesthesia for the obese patient. Curr Opin Anaesthesiol. 2006 Dec;19(6):597-9. doi: 10.1097/ACO.0b013e328010cb78.

  PMID: 17093361 RESULT

• 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.

  PMID: 18635478 RESULT

• 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.

  PMID: 20576632 RESULT

Study Officials

• Pierre Y Garneau, MD

  Hopital Sacre Coeur de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, General Surgery Department

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 19, 2015

Record last verified: 2015-08