Back to resultsA Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum (LEOPARD-3)
Primary Purpose
Nephrostomy; Complications, Pneumoperitoneum, Observation of Neuromuscular Block
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Deep neuromsucular block
Sponsored by
About this trial
This is an interventional treatment trial for Nephrostomy; Complications
Eligibility Criteria
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
Sites / Locations
- Radboud University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Deep neuromsucular block
Standard neuromuscular block
Arm Description
Deep neuromuscular block and low pressure pneumoperitoneum
Standard neuromuscular block and low pressure pneumoperitoneum
Outcomes
Primary Outcome Measures
Mean surgical rating score
Secondary Outcome Measures
Conversion to standard pressure pneumoperitoneum
Intra-operative complications
Length of pneumoperitoneum
Full Information
NCT ID
NCT02602964
First Posted
May 13, 2015
Last Updated
April 1, 2016
Sponsor
Radboud University Medical Center
Collaborators
Leiden University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02602964
Brief Title
A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum
Acronym
LEOPARD-3
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Leiden University Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrostomy; Complications, Pneumoperitoneum, Observation of Neuromuscular Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep neuromsucular block
Arm Type
Experimental
Arm Description
Deep neuromuscular block and low pressure pneumoperitoneum
Arm Title
Standard neuromuscular block
Arm Type
No Intervention
Arm Description
Standard neuromuscular block and low pressure pneumoperitoneum
Intervention Type
Other
Intervention Name(s)
Deep neuromsucular block
Intervention Description
Deep or standard neuromuscular block
Primary Outcome Measure Information:
Title
Mean surgical rating score
Time Frame
perioperative
Secondary Outcome Measure Information:
Title
Conversion to standard pressure pneumoperitoneum
Time Frame
perioperative
Title
Intra-operative complications
Time Frame
perioperative
Title
Length of pneumoperitoneum
Time Frame
perioperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Özdemir-van Brunschot, MD PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
34879862
Citation
Reijnders-Boerboom GTJA, van Helden EV, Minnee RC, Albers KI, Bruintjes MHD, Dahan A, Martini CH, d'Ancona FCH, Scheffer GJ, Keijzer C, Warle MC. Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1.
Results Reference
derived
PubMed Identifier
28643056
Citation
Ozdemir-van Brunschot DMD, Braat AE, van der Jagt MFP, Scheffer GJ, Martini CH, Langenhuijsen JF, Dam RE, Huurman VA, Lam D, d'Ancona FC, Dahan A, Warle MC. Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc. 2018 Jan;32(1):245-251. doi: 10.1007/s00464-017-5670-2. Epub 2017 Jun 22.
Results Reference
derived
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A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum
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