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

Phase 4

Completed

• Conditions: Surgical Conditions
• Interventions: Drug: Rocuronium

• Registration Number: NCT02553629
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-28
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2016-07-14
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-11
• Last Update Submitted: 2016-12-11
• Results First Posted: 2017-02-03
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deep neuromuscular block	Rocuronium	rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
moderate neuromuscular block	Rocuronium	rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches

Primary Outcome Measures

Name	Time	Method
Surgical Rating	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.

Secondary Outcome Measures

Name	Time	Method
Extubation	intraoperative	The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).
Pain	postoperative, for up to 2 hours	pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.
Respiration	2 hours postoperative	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.; The data were averaged per subject and the mean of the mean data are reported.
Mean Arterial Blood Pressure	2 hours postoperative	Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit.; The data will be averaged per subject and the mean of the mean values are reported.

Trial Locations

Locations (2)

Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek; 🇳🇱 The Hague, Zuid Holland, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands