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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02602964

Collaborator

Leiden University Medical Center (Other)

Enrollment

Location

Arms

10.1

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrostomy; Complications Pneumoperitoneum Observation of Neuromuscular Block	Other: Deep neuromsucular block	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean surgical rating score [perioperative]

Secondary Outcome Measures

Conversion to standard pressure pneumoperitoneum [perioperative]
Intra-operative complications [perioperative]
Length of pneumoperitoneum [perioperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Medical Center	Nijmegen		Netherlands	6500 HB

Sponsors and Collaborators

Radboud University Medical Center
Leiden University Medical Center

Investigators

Principal Investigator: Denise Özdemir-van Brunschot, MD PhD, Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radboud University Medical Center

ClinicalTrials.gov Identifier:

NCT02602964

Other Study ID Numbers:

NL50874.091.14

First Posted:

Nov 11, 2015

Last Update Posted:

Apr 4, 2016

Last Verified:

Apr 1, 2016

Additional relevant MeSH terms:

Pneumoperitoneum

Study Results

No Results Posted as of Apr 4, 2016