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

Surgery Clinical Trial

— RELAX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838134
• Other study ID #: NL58160.091.16
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: December 2, 2017

Study information

• Verified date: April 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.
• No additional Rocuronium
No additional rocuronium is administered after tracheal intubation.

Locations

Country	Name	City	State
Netherlands	LUMC	Leiden
Netherlands	Radboudumc	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Length of Pneumoperitoneum	Intraoperative parameter of duration of pneumoperitoneum	Day 0: once, up to 240 minutes
Secondary	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
Secondary	Estimated Blood Loss	Intraoperative parameter	Day 0: once, up to 240 minutes
Secondary	Conversion	Number of Participants with conversion to open or hand-assisted donor nephrectomy	Day 0: once, up to 240 minutes
Secondary	Intra-operative Complications	Number of Participants with Complications which occurred during surgery	Day 0: once, up to 240 minutes
Secondary	Cumulative Use of Rocuronium	Total amount of rocuronium administered during surgery	Day 0: once, up to 240 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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