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

NCT02553629 | Completed Phase 4 Results

• 1 other identifier: NL52829.058.15
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgical Conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Extubation

  intraoperative

• Pain

  postoperative, for up to 2 hours

• Respiration

  2 hours postoperative

• Mean Arterial Blood Pressure

  2 hours postoperative

Study Arms (2)

moderate neuromuscular block

ACTIVE COMPARATOR

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

Drug: Rocuronium

deep neuromuscular block

EXPERIMENTAL

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

Drug: Rocuronium

Interventions

Rocuronium DRUG

deep neuromuscular block; moderate neuromuscular block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III
• BMI \> 34 kg/m2
• Elective bariatric surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator
• Medical Center Haaglanden: collaborator

Study Sites (2)

Leiden University Medical Center

Leiden, South Holland, Netherlands

Location

Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek

The Hague, South Holland, Netherlands

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Prof. Dr. A. Dahan
• Organization: Leiden University Medical Center

a.dahan@lumc.nl

+31 71 526 2301

Study Officials

• Albert Dahan, MD, PhD, professor

  LUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, professor

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 3, 2017
• Results First Posted: February 3, 2017

Record last verified: 2016-12

Locations

NL (2)