NCT02838134

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	No additional Rocuronium	No additional rocuronium is administered after tracheal intubation.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-11-02
• Completion: 2017-12-02
• First posted: 2016-07-20
• Last updated: 2019-09-19
• Results posted: 2019-09-19

Locations

2 sites across 1 country: Netherlands