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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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