Clinical trial NCT02838134: Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
Official title: The Effectiveness of Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Block
Renal Transplant Donor of Left Kidney
Renal Transplant Donor of Right Kidney
Surgery
Keywords: Laparoscopic donor nephrectomy
Early quality of recovery
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-07-20
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Rationale: Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade (NMB) has shown to reduce postoperative pain scores after laparoscopic surgery. With this study the investigators will investigate if deep NMB also improves the early quality of recovery after LDN.

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.

Study design: A multicenter, blinded, randomized controlled trial

Study population: 96 adult patients (18 years or older), scheduled for living donor nephrectomy, will be randomized into a group with deep or moderate neuromuscular blockade. Deep neuromuscular blockade is defined as post tetanic count 1-2.

Main study parameters/endpoints: The primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.

Secondary outcomes measured are: intra-operative parameters (e.g. surgical conditions, operation time, length of pneumoperitoneum, first warm ischemia time, estimated blood loss, conversion to open or hand-assisted donor nephrectomy, intra-operative complications, cumulative use of rocuronium and sugammadex), the total score of the quality of Recovery-40 questionnaire at 48 hours after extubation, post-operative pain (components of pain scores); postoperative nausea and vomiting (NRS), the cumulative use of analgesics and anti-emetics, time to reach discharge criteria and postoperative complications.

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 \<30ml/min)
* Morbid obesity (BMI\>35 kg/m2)

Primary outcomes:
measure: Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)
timeFrame: Day 1: 24 hours after detubation
Secondary outcomes:
measure: Surgical Conditions
timeFrame: Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)
measure: Length of Pneumoperitoneum
timeFrame: Day 0: once, up to 240 minutes
measure: Warm Ischemia Time
timeFrame: Day 0: once, up to 240 minutes
measure: Estimated Blood Loss
timeFrame: Day 0: once, up to 240 minutes
measure: Conversion
timeFrame: Day 0: once, up to 240 minutes
measure: Intra-operative Complications
timeFrame: Day 0: once, up to 240 minutes
measure: Cumulative Use of Rocuronium
timeFrame: Day 0: once, up to 240 minutes
measure: Total Score of the Quality of Recovery-40 Questionnaire
timeFrame: Day 2: 48 hours after detubation
measure: Postoperative Pain
timeFrame: Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation
measure: Postoperative Complications
timeFrame: 24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery
measure: Discharge Criteria
timeFrame: 24 and 48 hours after detubation
measure: Pain Scores
timeFrame: once, 4 weeks after surgery
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Moira Bruintjes, Msc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Michiel Warlé, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: LUMC
name: Andries E Braat, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reijnders-Boerboom GTJA, van Helden EV, Minnee RC, Albers KI, Bruintjes MHD, Dahan A, Martini CH, d'Ancona FCH, Scheffer GJ, Keijzer C, Warle MC. Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1.
citation: Albers KI, van Helden EV, Dahan A, Martini CH, Bruintjes MHD, Scheffer GJ, Steegers MAH, Keijzer C, Warle MC. Early postoperative pain after laparoscopic donor nephrectomy predicts 30-day postoperative infectious complications: a pooled analysis of randomized controlled trials. Pain. 2020 Jul;161(7):1565-1570. doi: 10.1097/j.pain.0000000000001842.
citation: Bruintjes MHD, Krijtenburg P, Martini CH, Poyck PP, d'Ancona FCH, Huurman VAL, van der Jagt M, Langenhuijsen JF, Nijboer WN, van Laarhoven CJHM, Dahan A, Warle MC; RELAX collaborator group. Efficacy of profound versus moderate neuromuscular blockade in enhancing postoperative recovery after laparoscopic donor nephrectomy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):494-501. doi: 10.1097/EJA.0000000000000992.
citation: Bruintjes MH, Braat AE, Dahan A, Scheffer GJ, Hilbrands LB, d'Ancona FC, Donders RA, van Laarhoven CJ, Warle MC. Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study. Trials. 2017 Mar 4;18(1):99. doi: 10.1186/s13063-017-1785-y.