MRI Measurement of the Effects of Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopy (RELAX-2)

April 1, 2019 updated by: Radboud University Medical Center

MRI Measurement of the Effects of Moderate Versus Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopic Surgery in a Prospective Cohort Study.

During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum. Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the quality of the surgical space conditions during laparoscopy (1), showed that compared to moderate NMB, deep neuromuscular blockade improves the surgical space conditions, assessed by the Leiden-Surgical Rating scale, as reported by Martini and colleagues (2).

In this prospective cohort study, we will assess the influence of deep neuromuscular blockade on the surgical space, measured by magnetic resonance imaging (MRI) in patients scheduled for laparoscopic donor nephrectomy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: To establish the influence of deep neuromuscular blockade (NMB) on the abdominal working space during laparoscopy.

Study design: A single center prospective cohort study

Study population: 10 adult patients (18 years or older), equally distributed by gender, scheduled for laparoscopic donor nephrectomy

Study procedures:

Induction of general anesthesia followed by intubation and creation of a pneumoperitoneum (12 mmHg).

Each patient will have a MRI scan during 3 stages:

Phase 1: No neuromuscular blockade (TOF ratio 1) Phase 2: moderate neuromuscular blockade(TOF 1-3). Phase 3: deep neuromuscular blockade (PTC 0-1)

Primary outcome:

The abdominal space measured by MRI: Skin - sacral promontory distance

Secondary outcome:

3D volume measurement of the abdominal cavity by MRI.

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • scheduled for laparoscopic donor nephrectomy
  • obtained informed consent

Exclusion Criteria:

  • Unable to provide informed consent
  • known or suspect allergy to mivacurium, rocuronium or sugammadex
  • neuromuscular disease
  • indication for rapid sequence induction
  • Being unable to undergo MRI due to any reason (e.g. non MRI-compatible implants, epilepsy)
  • BMI>30 kg/m2
  • American Society of Anesthesiologists (ASA) classification >2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: No Rocuronium
Phase 1: no neuromuscular blockade
Procedure: No Rocuronium
Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.
Other Names:
  • No neuromuscular blockade
EXPERIMENTAL: Rocuronium (moderate NMB)
Phase 2: moderate neuromuscular blockade (TOF 1-3)
Drug: Rocuronium (moderate NMB)
Phase 2: Rocuronium will be titrated to a moderate NMB (TOF 1-3), monitored by TOF-watch. When an adequate moderate NMB is achieved, the patient will undergo a second MRI-abdomen.
Other Names:
  • Moderate neuromuscular blockade (Rocuronium)
EXPERIMENTAL: Rocuronium (deep NMB)
Phase 3: deep neuromuscular blockade (PTC 0-1)
Drug: Rocuronium (deep NMB)
Phase 3: The patient receives a bolus of 1.2 mg/kg rocuronium (adjusted to ideal body weight), to assure a deep or intense NMB (PTC 0-1). Then the patient will undergo the final, third MRI scan of the abdomen.
Other Names:
  • Deep neuromuscular blockade (Rocuronium)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal working space
Time Frame: 3 times (phase 1 (no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes
Skin-sacral promontory distance, measured by MRI
3 times (phase 1 (no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal volume
Time Frame: 3 times (phase 1 no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes
3D volume abdominal cavity, measured by MRI
3 times (phase 1 no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Michiel C Warlé, Dr., Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2019

Primary Completion (ANTICIPATED)

November 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (ACTUAL)

September 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63227.091.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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