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Completed

NCT Number: NCT02602964

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

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.

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Key information

Conditions

Nephrostomy; Complications Digestive System Diseases Observation of Neuromuscular Block Peritoneal Diseases Pneumoperitoneum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep neuromsucular block

Other

Deep or standard neuromuscular block

Primary outcomes

  1. Mean surgical rating score

    Time frame: perioperative

Secondary outcomes

  1. Conversion to standard pressure pneumoperitoneum

    Time frame: perioperative

  2. Intra-operative complications

    Time frame: perioperative

  3. Length of pneumoperitoneum

    Time frame: perioperative

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Leiden University Medical Center

Registry information

Official study title

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

Acronym: LEOPARD-3

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2015
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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