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Completed

NCT Number: NCT02838134

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LUMC, Leiden, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rocuronium

Other

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

Other

No additional rocuronium is administered after tracheal intubation.

Primary outcomes

  1. Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)

    Time frame: 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 outcomes

  1. Surgical Conditions

    Time frame: 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.

    • = extremely poor conditions
    • = poor conditions
    • = acceptable conditions
    • =good conditions
    • = optimal conditions
  2. Length of Pneumoperitoneum

    Time frame: Day 0: once, up to 240 minutes

    Intraoperative parameter of duration of pneumoperitoneum

  3. Warm Ischemia Time

    Time frame: 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

  4. Estimated Blood Loss

    Time frame: Day 0: once, up to 240 minutes

    Intraoperative parameter

  5. Conversion

    Time frame: Day 0: once, up to 240 minutes

    Number of Participants with conversion to open or hand-assisted donor nephrectomy

  6. Intra-operative Complications

    Time frame: Day 0: once, up to 240 minutes

    Number of Participants with Complications which occurred during surgery

  7. Cumulative Use of Rocuronium

    Time frame: Day 0: once, up to 240 minutes

    Total amount of rocuronium administered during surgery

  8. Total Score of the Quality of Recovery-40 Questionnaire

    Time frame: 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.

  9. Postoperative Pain

    Time frame: 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.

  10. Postoperative Complications

    Time frame: 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

  11. Discharge Criteria

    Time frame: 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.

  12. Pain Scores

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: RELAX

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2016
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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