Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients (BLISS3)

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Conditions
• Intervention / Treatment: Drug: Rocuronium

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • The Hague, Zuid Holland, Netherlands
      • Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands
      • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: moderate neuromuscular block; rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches	Drug: Rocuronium
Experimental: deep neuromuscular block; rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches	Drug: Rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The rating scale will be averaged for each subject and the mean values will be reported.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pain	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.	postoperative, for up to 2 hours
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. The data were averaged per subject and the mean of the mean data are reported.	2 hours postoperative
Mean Arterial Blood Pressure	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.	2 hours postoperative

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Merck Sharp & Dohme LLC; Medical Center Haaglanden
• Investigators: Principal Investigator: Albert Dahan, MD, PhD, professor, LUMC

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: NL52829.058.15