The effectiveness of deep muscle relaxation on recovery after kidney donation.
Phase 1
- Conditions
- ive kidney donation is currently the most effect strategy to manage the shortage of donor kindeys for transplantation.Optimizing the safety and postoperative recovery after laparoscopic donornephrectomy is of great importance to increase the number of living kindey donors. We will investigate the effect of deep neuromuscular blockade on the quality of the early recovery after laparoscopic donornephrectomy.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2016-002924-99-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
All patients scheduled for live kidney donation:
- 18 years or older
- obtained informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
. insufficient control of the Dutch language to read the patient information and to fìll out the questionnaires
. chronic use of analgesics or psychotropic drugs
. use of NSAIDs shorter than 5 days before surgery
. known or suspect allergy to rocuronium of sugammadex
. neuromuscular disease
. indication for rapid sequence induction
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) -with standard pressure pneumoperitoneum- and the early quality of recovery.;Secondary Objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) on the postoperative painscores, postoperative cumulative use analgesics and anti-emetics, and complications;Primary end point(s): The Quality of Recovery score (QoR-40 questionnaire);Timepoint(s) of evaluation of this end point: 24 hours after detubation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Quality of Recovery score (QoR 40 questionnaire)<br>Differentiated pain scores<br>Cumulative us e of analgesics and anti-emetics<br>Discharge criteria<br>Complications<br>Work and Healthcare questionnaire;Timepoint(s) of evaluation of this end point: Quality of Recovery score: 48 hours after detubation<br>Differentiated pain scores: 1, 4, 8, 24 and 48 hours after detubation and after 4 weeks<br>Cumulative us e of analgesics and anti-emetics: 1, 4, 8, 24 and 48 hours after detubation<br>Discharge criteria: 8, 24 and 48 hours after detubation<br>Complications: 24 and 48 hours after detubation and after 4 weeks<br>Work and Healthcare questionnaire: 4 weeks postoperative