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

Radboud University Medical Center

Status and phase

Completed

Phase 4

Conditions

Neuromuscular Block

Renal Transplant Donor of Right Kidney

Surgery

Renal Transplant Donor of Left Kidney

Treatments

Other: Rocuronium

Other: No additional Rocuronium

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02838134

NL58160.091.16

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)