NCT02838134

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 19, 2019

Completed
Last Updated

September 19, 2019

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

June 29, 2016

Results QC Date

March 20, 2019

Last Update Submit

August 16, 2019

Conditions

Neuromuscular BlockRenal Transplant Donor of Left KidneyRenal Transplant Donor of Right KidneySurgery

Keywords

Laparoscopic donor nephrectomyEarly quality of recovery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Surgical Conditions

    Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)

  • Length of Pneumoperitoneum

    Day 0: once, up to 240 minutes

  • Warm Ischemia Time

    Day 0: once, up to 240 minutes

  • Estimated Blood Loss

    Day 0: once, up to 240 minutes

  • Conversion

    Day 0: once, up to 240 minutes

  • +7 more secondary outcomes

Study Arms (2)

Group A: Deep Neuromuscular blockade

EXPERIMENTAL

An extra bolus of rocuronium after intubation followed by infusion

Other: Rocuronium

Group B: Moderate neuromuscular Blockade

SHAM COMPARATOR

Moderate neuromuscular Blockade No additional rocuronium after intubation.

Other: No additional Rocuronium

Interventions

RocuroniumOTHER

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.

Group A: Deep Neuromuscular blockade
No additional RocuroniumOTHER

No additional rocuronium is administered after tracheal intubation.

Group B: Moderate neuromuscular Blockade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obtained informed consent
  • age over 18 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LUMC

Leiden, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

Related Publications (4)

  • Reijnders-Boerboom GTJA, van Helden EV, Minnee RC, Albers KI, Bruintjes MHD, Dahan A, Martini CH, d'Ancona FCH, Scheffer GJ, Keijzer C, Warle MC. Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1.

    PMID: 34879862DERIVED

  • Albers KI, van Helden EV, Dahan A, Martini CH, Bruintjes MHD, Scheffer GJ, Steegers MAH, Keijzer C, Warle MC. Early postoperative pain after laparoscopic donor nephrectomy predicts 30-day postoperative infectious complications: a pooled analysis of randomized controlled trials. Pain. 2020 Jul;161(7):1565-1570. doi: 10.1097/j.pain.0000000000001842.

    PMID: 32107359DERIVED

  • Bruintjes MHD, Krijtenburg P, Martini CH, Poyck PP, d'Ancona FCH, Huurman VAL, van der Jagt M, Langenhuijsen JF, Nijboer WN, van Laarhoven CJHM, Dahan A, Warle MC; RELAX collaborator group. Efficacy of profound versus moderate neuromuscular blockade in enhancing postoperative recovery after laparoscopic donor nephrectomy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):494-501. doi: 10.1097/EJA.0000000000000992.

    PMID: 30920983DERIVED

  • Bruintjes MH, Braat AE, Dahan A, Scheffer GJ, Hilbrands LB, d'Ancona FC, Donders RA, van Laarhoven CJ, Warle MC. Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study. Trials. 2017 Mar 4;18(1):99. doi: 10.1186/s13063-017-1785-y.

    PMID: 28259181DERIVED

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

It appeared to be difficult to achieve and maintain the intended depth of neuromuscular blockade. Despite high dosages of rocuronium with continuous infusion, the intended deep NMB was not achieved in all patients within the deep NMB group.

Results Point of Contact

Title
Dr M.C. Warlé
Organization
Radboud University Medical Center
Michiel.Warlé@radboudumc.nl
+31-24362415333

Study Officials

  • Moira Bruintjes, Msc.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Michiel Warlé, Dr.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Andries E Braat, Dr.

    LUMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 20, 2016

Study Start

November 1, 2016

Primary Completion

November 2, 2017

Study Completion

December 2, 2017

Last Updated

September 19, 2019

Results First Posted

September 19, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)