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Clinical Trials/NCT02300168
NCT02300168
Completed
N/A

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

Hopital du Sacre-Coeur de Montreal0 sites50 target enrollmentSeptember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bariatric Surgery Candidate
Sponsor
Hopital du Sacre-Coeur de Montreal
Enrollment
50
Primary Endpoint
surgeon evaluation of working surgical conditions
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pierre Garneau

Chief, General Surgery Department

Hopital du Sacre-Coeur de Montreal

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.

Outcomes

Primary Outcomes

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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