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

Phase 4

Completed

• Conditions: Renal Transplant Donor of Left Kidney; Neuromuscular Block; Renal Transplant Donor of Right Kidney; Surgery
• Interventions: Other: No additional Rocuronium; Other: Rocuronium

• Registration Number: NCT02838134
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-20
• Study Start: 2016-11
• Primary Completion: 2017-11-02
• Study Completion: 2017-12-02
• Status Verified: 2018-04
• Results First Submitted: 2019-03-20
• Results First Submitted QC: 2019-08-16
• Last Update Submitted: 2019-08-16
• Results First Posted: 2019-09-19
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• obtained informed consent
• age over 18 years

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: Moderate neuromuscular Blockade	No additional Rocuronium	Moderate neuromuscular Blockade No additional rocuronium after intubation.
Group A: Deep Neuromuscular blockade	Rocuronium	An extra bolus of rocuronium after intubation followed by infusion

Primary Outcome Measures

Name	Time	Method
Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)	Day 1: 24 hours after detubation	The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome

Secondary Outcome Measures

Name	Time	Method
Conversion	Day 0: once, up to 240 minutes	Number of Participants with conversion to open or hand-assisted donor nephrectomy
Surgical Conditions	Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)	Surgical rating score, concerning the quality of the surgical field, scored with the surgical rating scale (SRS) A likert scale from 1 to 5. Higher scores represent better outcomes.; 1. = extremely poor conditions; 2. = poor conditions; 3. = acceptable conditions; 4. =good conditions; 5. = optimal conditions
Warm Ischemia Time	Day 0: once, up to 240 minutes	Intraoperative parameter measuring the time (in minutes) between dissection of the renal artery and flushing of the kidney after retrieval
Postoperative Complications	24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery	Number of participants with postoperative complications that occurred up to 8 weeks after surgery
Cumulative Use of Rocuronium	Day 0: once, up to 240 minutes	Total amount of rocuronium administered during surgery
Total Score of the Quality of Recovery-40 Questionnaire	Day 2: 48 hours after detubation	The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome.
Postoperative Pain	Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation	components of pain scores after 1 hour, 6 hours, on postoperative day 1 (POD1) and postoperative day 2 (POD2).; Likert scale from 0 to 10. Higher scores represent more pain.
Length of Pneumoperitoneum	Day 0: once, up to 240 minutes	Intraoperative parameter of duration of pneumoperitoneum
Estimated Blood Loss	Day 0: once, up to 240 minutes	Intraoperative parameter
Intra-operative Complications	Day 0: once, up to 240 minutes	Number of Participants with Complications which occurred during surgery
Discharge Criteria	24 and 48 hours after detubation	Scoring the following criteria: adequate pain control with oral medication, passage of flatus or defecation, intake of solid food tolerated, patient is mobilized and independent and patient accepts discharge.
Pain Scores	once, 4 weeks after surgery	Total amount of pain 4 weeks after surgery Likert scale from 0 to 10. Higher scores represent more pain (worse outcome).

Trial Locations

Locations (2)

Radboudumc; 🇳🇱 Nijmegen, Netherlands

LUMC; 🇳🇱 Leiden, Netherlands