Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients

Surgical Conditions Clinical Trial

— BLISS3  

Official title:

Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02553629
• Other study ID #: NL52829.058.15
• Status: Recruiting
• Phase: Phase 4
• First received: August 28, 2015
• Last updated: September 21, 2015
• Start date: September 2015

Study information

• Verified date: September 2015
• Source: Leiden University Medical Center
• Contact: Albert Dahan, MD, PhD, professor
• Phone: +31 71 526 2301
• Email: a.dahan[@]lumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA I-III

• BMI > 34 kg/m2

• Elective bariatric surgery.

Exclusion Criteria:

• Known or suspected neuromuscular disorders impairing neuromuscular function

• Allergies to muscle relaxants, anesthetics or narcotics

• A(family) history of malignant hyperthermia

• Women who are or may be pregnant or are currently breast feeding

• Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Surgical Conditions

Intervention

Drug:
• Rocuronium

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland
Netherlands	Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek	The Hague	Zuid Holland

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	Medical Center Haaglanden, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical rating	During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated.	intraoperative	No
Secondary	Extubation	The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).	intraoperative	No
Secondary	Pain	pain will be scored using numeric rating scale (0-10) at 10 minute intervals at the post anesthesia care unit	up to 2 hours postoperative	No
Secondary	Respiration	Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged.	2 hours postoperative	No
Secondary	Hemodynamics	Hemodynamics will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit by measurement of heart rate (unit 1/min) and diastolic and systolic blood pressure (unit mm Hg).	2 hours postoperative	No
Secondary	Quality of Recovery Score	Postoperative Quality of Recovery Score at 10 min and at 40 min in the recovery room (one additional measurement will be obtained at day 1 after surgery); one additional measurement will be at 18-24 h post operative.	At 10 and 40 minutes after arrival on PACU, and 18-24 hr postoperatively on ward	No