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

Phase 4

Completed

• Conditions: Pneumoperitoneum; Observation of Neuromuscular Block; Nephrostomy; Complications
• Interventions: Other: Deep neuromsucular block

• Registration Number: NCT02602964
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• obtained informed consent
• age over 18 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep neuromsucular block	Deep neuromsucular block	Deep neuromuscular block and low pressure pneumoperitoneum

Primary Outcome Measures

Name	Time	Method
Mean surgical rating score	perioperative

Secondary Outcome Measures

Name	Time	Method
Conversion to standard pressure pneumoperitoneum	perioperative
Length of pneumoperitoneum	perioperative
Intra-operative complications	perioperative

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands