Neuromuscular BlockPhase 4RELAXNCT02838134
Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
A Phase 4 study testing Rocuronium and No additional Rocuronium in people with Neuromuscular Block and Renal Transplant Donor of Left Kidney, run by Radboud University Medical Center at 2 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Block, Renal Transplant Donor of Left Kidney, Renal Transplant Donor of Right Kidney
- What is being tested?
- Rocuronium and No additional Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2016to 2 Dec 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obtained informed consent
- age over 18 years
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Effectiveness of 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.
Read the 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
- Being tested
- Rocuronium, No additional Rocuronium
- Keywords
- Laparoscopic donor nephrectomy, Early quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
No additional RocuroniumOther
No additional rocuronium is administered after tracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Deep Neuromuscular blockade | Experimental | An extra bolus of rocuronium after intubation followed by infusion Receives: Other: Rocuronium |
| Group B: Moderate neuromuscular Blockade | Sham comparator | Moderate neuromuscular Blockade No additional rocuronium after intubation. Receives: Other: No additional Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1: 24 hours after detubation
Secondary outcomes (12)
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
Measured: Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)
Length of Pneumoperitoneum
Intraoperative parameter of duration of pneumoperitoneum
Measured: Day 0: once, up to 240 minutes
Warm Ischemia Time
Intraoperative parameter measuring the time (in minutes) between dissection of the renal artery and flushing of the kidney after retrieval
Measured: Day 0: once, up to 240 minutes
Estimated Blood Loss
Intraoperative parameter
Measured: Day 0: once, up to 240 minutes
Conversion
Number of Participants with conversion to open or hand-assisted donor nephrectomy
Measured: Day 0: once, up to 240 minutes
Intra-operative Complications
Number of Participants with Complications which occurred during surgery
Measured: Day 0: once, up to 240 minutes
Cumulative Use of Rocuronium
Total amount of rocuronium administered during surgery
Measured: Day 0: once, up to 240 minutes
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.
Measured: Day 2: 48 hours after detubation
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.
Measured: Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation
Postoperative Complications
Number of participants with postoperative complications that occurred up to 8 weeks after surgery
Measured: 24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery
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.
Measured: 24 and 48 hours after detubation
Pain Scores
Total amount of pain 4 weeks after surgery Likert scale from 0 to 10. Higher scores represent more pain (worse outcome).
Measured: once, 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startNov 2016
- Primary completion2 Nov 2017
- Study completion2 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Moira Bruintjes, Msc., Principal investigator, Radboud University Medical CenterMichiel Warlé, Dr., Principal investigator, Radboud University Medical CenterAndries E Braat, Dr., Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838134
- Sponsor's protocol ID
- NL58160.091.16
- Acronym
- RELAX
- Status last verified
- Apr 2018
- First submitted
- 29 Jun 2016
- Last updated
- 19 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34879862Albers 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.
PubMed 32107359Bruintjes 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.
PubMed 30920983Bruintjes 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.
PubMed 28259181
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
- ClinicalTrials.gov ID
- NCT02838134
- Acronym / sponsor ID
- RELAX / NL58160.091.16
- Conditions
- Neuromuscular Block, Renal Transplant Donor of Left Kidney, Renal Transplant Donor of Right Kidney, Surgery
- Keywords
- Laparoscopic donor nephrectomy, Early quality of recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2016 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Dec 2017 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Deep Neuromuscular blockade | Experimental | Other: RocuroniumAn extra bolus of rocuronium after intubation followed by infusion |
| Group B: Moderate neuromuscular Blockade | Sham comparator | Other: No additional RocuroniumModerate neuromuscular Blockade No additional rocuronium after intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- obtained informed consent
- age over 18 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RocuroniumA 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 | Group A: Deep Neuromuscular blockade |
| No additional RocuroniumNo additional rocuronium is administered after tracheal intubation. | Other | Group B: Moderate neuromuscular Blockade |
Primary outcome
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
12 secondary outcomes
Surgical Conditions
Time frame: Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)
Length of Pneumoperitoneum
Time frame: Day 0: once, up to 240 minutes
Warm Ischemia Time
Time frame: Day 0: once, up to 240 minutes
Estimated Blood Loss
Time frame: Day 0: once, up to 240 minutes
Conversion
Time frame: Day 0: once, up to 240 minutes
Intra-operative Complications
Time frame: Day 0: once, up to 240 minutes
Cumulative Use of Rocuronium
Time frame: Day 0: once, up to 240 minutes
Total Score of the Quality of Recovery-40 Questionnaire
Time frame: Day 2: 48 hours after detubation
Postoperative Pain
Time frame: Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation
Postoperative Complications
Time frame: 24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery
Discharge Criteria
Time frame: 24 and 48 hours after detubation
Pain Scores
Time frame: once, 4 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34879862Reijnders-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.
- Derived from this study: PubMed 32107359Albers 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.
- Derived from this study: PubMed 30920983Bruintjes 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.
- Derived from this study: PubMed 28259181Bruintjes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moira Bruintjes, Msc. principal investigator
Radboud University Medical Center
Michiel Warlé, Dr. principal investigator
Radboud University Medical Center
Andries E Braat, Dr. principal investigator
LUMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium and No additional Rocuronium in people with Neuromuscular Block and Renal Transplant Donor of Left Kidney, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score of the Quality of Recovery-40 Questionnaire (QoR-40) (time frame: Day 1: 24 hours after detubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838134, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.