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The effectiveness of deep muscle relaxation on recovery after kidney donation.

The effectiveness of deep versus moderate neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery. - RELAX study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-002924-99-NL
Enrollment
96
Registered
2016-08-08
Start date
2016-10-27
Completion date
Unknown
Last updated
2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Live 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.

Interventions

Trade Name: Esmeron (Rocuroniumbromide) Pharmaceutical Form: Solution for injection Trade Name: Bridion Product Name: Bridion Pharmaceutical Form: Solution for infusion

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): Quality of Recovery score (QoR 40 questionnaire) Differentiated pain scores Cumulative us e of analgesics and anti-emetics Discharge criteria Complications Work and Healthcare questionnaire;Timepoint(s) of evaluation of this end point: Quality of Recovery score: 48 hours after detubation Differentiated pain scores: 1, 4, 8, 24 and 48 hours after detubation and after 4 weeks Cumulative us e of analgesics and anti-emetics: 1, 4, 8, 24 and 48 hours after detubation Discharge criteria: 8, 24 and 48 hours after detubation Complications: 24 and 48 hours after detubation and after 4 weeks Work and Healthcare questionnaire: 4 weeks postoperative

Countries

Netherlands

Contacts

Public ContactRELAX information

Radboudumc

Moira.Bruintjes@radboudumc.nl+31243615333

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026