Phase 4
N=101
Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
Neuromuscular Block · Renal Transplant Donor of Left Kidney · Renal Transplant Donor of Right Kidney · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02838134 ↗Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Sep 2019
Primary outcome: Primary: Total Score of the Quality of Recovery-40 Questionnaire (QoR-40) — 169.3; 169.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rocuronium (Other); No additional Rocuronium (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Radboud University Medical Center
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Score of the Quality of Recovery-40 Questionnaire (QoR-40) |
169.3; 169.5 | — |
| SECONDARY Surgical Conditions |
4.8; 4.7 | — |
| SECONDARY Length of Pneumoperitoneum |
122.8; 113.8 | — |
| SECONDARY Warm Ischemia Time |
3.6; 3.9 | — |
| SECONDARY Estimated Blood Loss |
60.2; 69.1 | — |
| SECONDARY Conversion |
0; 2 | — |
| SECONDARY Intra-operative Complications |
1; 6 | — |
| SECONDARY Cumulative Use of Rocuronium |
184.6; 67.0 | — |
| SECONDARY Total Score of the Quality of Recovery-40 Questionnaire |
175.6; 175.3 | — |
| SECONDARY Postoperative Pain |
4.0; 4.31; 0.0; 0.3; 3.7; 4.5 | — |
| SECONDARY Postoperative Complications |
2; 4; 7; 5; 9; 5 | — |
| SECONDARY Discharge Criteria |
13; 15; 24; 29 | — |
| SECONDARY Pain Scores |
1.88; 1.85 | — |
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.
Eligibility Criteria
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 35 kg/m2)
Data sourced from ClinicalTrials.gov (NCT02838134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.