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

Leiden University Medical Center2 sites in 1 country109 target enrollmentSeptember 2015

ConditionsSurgical Conditions

InterventionsRocuronium

Overview

Phase: Phase 4
Intervention: Rocuronium
Conditions: Surgical Conditions
Sponsor: Leiden University Medical Center
Enrollment: 109
Locations: 2
Primary Endpoint: Surgical Rating
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Leiden University Medical Center

Responsible Party

Principal Investigator

Albert Dahan

MD, PhD, professor

Leiden University Medical Center

Eligibility Criteria

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.

Arms & Interventions

moderate neuromuscular block

rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches

Intervention: Rocuronium

deep neuromuscular block

rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches

Intervention: Rocuronium

Outcomes

Primary Outcomes

Surgical Rating

Time Frame: intraoperative

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. The rating scale will be averaged for each subject and the mean values will be reported.