A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum (LEOPARD-3)

April 1, 2016 updated by: Radboud University Medical Center

A Randomized Controlled Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum - to Optimize the Surgical Conditions During Laparoscopic Donor Nephrectomy

Live kidney transplantation is first choice for patients with end-stage kidney disease. Therefore, the safety and well-being of kidneys donors are highly important objectives in live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and therefore also concomitant use of opioids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

However low pressure pneumoperitoneum can also decrease peri-operative conditions. In this trial the researchers will investigate whether peri-operative conditions during low pressure pneumoperitoneum can be optimized by the use of deep neuromuscular block.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Medical Center

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:

  • obtained informed consent
  • age over 18 years

Exclusion Criteria:

  • chronic use of analgesics or psychotropic drugs
  • use of non-steroidal anti-inflammatory drugs shorter than 5 days before surgery
  • known or suspect allergy to rocuronium or sugammadex
  • significant liver or renal dysfunction
  • pregnant or breastfeeding

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deep neuromsucular block
Deep neuromuscular block and low pressure pneumoperitoneum
Other: Deep neuromsucular block
Deep or standard neuromuscular block
No Intervention: Standard neuromuscular block
Standard neuromuscular block and low pressure pneumoperitoneum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean surgical rating score
Time Frame: perioperative
perioperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Conversion to standard pressure pneumoperitoneum
Time Frame: perioperative
perioperative
Intra-operative complications
Time Frame: perioperative
perioperative
Length of pneumoperitoneum
Time Frame: perioperative
perioperative

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Collaborators

Leiden University Medical Center

Investigators

  • Principal Investigator: Denise Özdemir-van Brunschot, MD PhD, 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

April 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

April 1, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL50874.091.14

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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