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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02838134
Other study ID # NL58160.091.16
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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