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Clinical Trials/NCT02602964
NCT02602964
Completed
Phase 4

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

Radboud University Medical Center1 site in 1 country34 target enrollmentApril 2015

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Nephrostomy; Complications
Sponsor
Radboud University Medical Center
Enrollment
34
Locations
1
Primary Endpoint
Mean surgical rating score
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
February 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Mean surgical rating score

Time Frame: perioperative

Secondary Outcomes

  • Conversion to standard pressure pneumoperitoneum(perioperative)
  • Length of pneumoperitoneum(perioperative)
  • Intra-operative complications(perioperative)

Study Sites (1)

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