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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
101
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.
No additional rocuronium is administered after tracheal intubation.
LUMC
Leiden, Netherlands
Radboudumc
Nijmegen, Netherlands
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
Time frame: Day 1: 24 hours after detubation
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. 1. = extremely poor conditions 2. = poor conditions 3. = acceptable conditions 4. =good conditions 5. = optimal conditions
Time frame: Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)
Length of Pneumoperitoneum
Intraoperative parameter of duration of pneumoperitoneum
Time frame: 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
Time frame: Day 0: once, up to 240 minutes
Estimated Blood Loss
Intraoperative parameter
Time frame: Day 0: once, up to 240 minutes
Conversion
Number of Participants with conversion to open or hand-assisted donor nephrectomy
Time frame: Day 0: once, up to 240 minutes
Intra-operative Complications
Number of Participants with Complications which occurred during surgery
Time frame: Day 0: once, up to 240 minutes
Cumulative Use of Rocuronium
Total amount of rocuronium administered during surgery
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: once, 4 weeks after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.