CompletedPhase 4

Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery

Netherlands101 participantsStarted 2016-11

Plain-language summary

Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the consequences of postoperative pain and analgesia consumptions. The investigators' goal is to establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the investigators designed a trial in which patients scheduled for living donor nephrectomy are randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

All adult individuals, who are scheduled for living kidney donation. Inclusion Criteria: * obtained informed consent * age over 18 years Exclusion Criteria: * insufficient control of the Dutch language to read the patient information and to fill 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 * deficiency of vitamin K-dependent clotting factors, coagulopathy or active use of coumarin derivates. * Peri-operative use of fusidic acid or flucloxacillin * Severe renal impairment (creatinine clearance \<30ml/min) * Morbid obesity (BMI\>35 kg/m2)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)

Timeframe: Day 1: 24 hours after detubation

Trial details

NCT IDNCT02838134

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-02

Results submitted2019-03-20

View on ClinicalTrials.gov More Neuromuscular Block trials