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

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ClinicalTrials.gov Identifier: NCT02602964
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : April 4, 2016
Sponsor:
Collaborator:
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.

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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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02602964


Locations
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Netherlands
Radboud University Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Leiden University Medical Center
Investigators
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Principal Investigator: Denise Özdemir-van Brunschot, MD PhD Radboud University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov 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:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases