COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02602964
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : April 4, 2016
Leiden University Medical Center
Information provided by (Responsible Party):
Radboud University

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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

Primary Outcome Measures :
  1. Mean surgical rating score [ Time Frame: perioperative ]

Secondary Outcome Measures :
  1. Conversion to standard pressure pneumoperitoneum [ Time Frame: perioperative ]
  2. Intra-operative complications [ Time Frame: perioperative ]
  3. Length of pneumoperitoneum [ Time Frame: perioperative ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02602964

Layout table for location information
Radboud University Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Leiden University Medical Center
Layout table for investigator information
Principal Investigator: Denise Özdemir-van Brunschot, MD PhD Radboud University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Radboud University Identifier: NCT02602964    
Other Study ID Numbers: NL50874.091.14
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Peritoneal Diseases
Digestive System Diseases