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Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02300168
Enrollment
50
Registered
2014-11-24
Start date
2014-09-30
Completion date
2014-12-31
Last updated
2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

Keywords

bariatric surgery; neuromuscular blockade

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.

Interventions

PROCEDURESleeve 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.

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
surgeon evaluation of working surgical conditionsintraoperativethe surgeon will score the surgical working conditions at 15 min intervals, according to a 5-point ordinal scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026