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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neuromuscular Block Renal Transplant Donor of Left Kidney Renal Transplant Donor of Right Kidney Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A: Deep Neuromuscular blockade

An extra bolus of rocuronium after intubation followed by infusion

Group Type EXPERIMENTAL

Rocuronium

Intervention Type OTHER

A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.

Group B: Moderate neuromuscular Blockade

Moderate neuromuscular Blockade No additional rocuronium after intubation.

Group Type SHAM_COMPARATOR

No additional Rocuronium

Intervention Type OTHER

No additional rocuronium is administered after tracheal intubation.

Interventions

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Rocuronium

A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.

Intervention Type OTHER

No additional Rocuronium

No additional rocuronium is administered after tracheal intubation.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No