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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02300168
Other study ID # MISP-51834
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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