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Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02300168
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : August 19, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Pierre Garneau, 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.

Condition or disease Intervention/treatment
Bariatric Surgery Candidate Procedure: Sleeve gastrectomy

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.


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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neuromuscular Blockade as a Determinant of Surgical Outcome and Post-operative Recovery, in Patients Undergoing Elective Laparoscopic Bariatric Surgery
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MO patients from the bariatric surgery department of Hopital Sacre Coeur de Montreal
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300168


Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Pierre Y Garneau, MD Hopital Sacre Coeur de Montreal