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

Study Overview
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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.

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.

Official Title
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The Effectiveness of Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery

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

Intervention / Treatment
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* Other: Rocuronium
* Other: No additional Rocuronium


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Deep Neuromuscular blockade<br>An extra bolus of rocuronium after intubation followed by infusion | Other: Rocuronium<br>* 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.<br>|
| Sham Comparator: Group B: Moderate neuromuscular Blockade<br>Moderate neuromuscular Blockade No additional rocuronium after intubation. | Other: No additional Rocuronium<br>* No additional rocuronium is administered after tracheal intubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Score of the Quality of Recovery-40 Questionnaire (QoR-40) | 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 | Day 1: 24 hours after detubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Conditions | 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. = extremely poor conditions = poor conditions = acceptable conditions =good conditions = optimal conditions | Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes) | 
| Length of Pneumoperitoneum | Intraoperative parameter of duration of pneumoperitoneum | Day 0: once, up to 240 minutes | 
| Warm Ischemia Time | Intraoperative parameter measuring the time (in minutes) between dissection of the renal artery and flushing of the kidney after retrieval | Day 0: once, up to 240 minutes | 
| Estimated Blood Loss | Intraoperative parameter | Day 0: once, up to 240 minutes | 
| Conversion | Number of Participants with conversion to open or hand-assisted donor nephrectomy | Day 0: once, up to 240 minutes | 
| Intra-operative Complications | Number of Participants with Complications which occurred during surgery | Day 0: once, up to 240 minutes | 
| Cumulative Use of Rocuronium | Total amount of rocuronium administered during surgery | Day 0: once, up to 240 minutes | 
| Total Score of the Quality of Recovery-40 Questionnaire | 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. | Day 2: 48 hours after detubation | 
| Postoperative Pain | 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. | Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation | 
| Postoperative Complications | Number of participants with postoperative complications that occurred up to 8 weeks after surgery | 24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery | 
| Discharge Criteria | 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. | 24 and 48 hours after detubation | 
| Pain Scores | Total amount of pain 4 weeks after surgery Likert scale from 0 to 10. Higher scores represent more pain (worse outcome). | once, 4 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic donor nephrectomy, Early quality of recovery