Trial Outcomes & Findings for Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery (NCT NCT02838134)
NCT ID: NCT02838134
Last Updated: 2019-09-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
Day 1: 24 hours after detubation
Results posted on
2019-09-19
Participant Flow
26 patients were assessed for eligibility but excluded, 8 patients did not meet the inclusion criteria 18 patients declined to participate
Participant milestones
| Measure |
Group A: Deep Neuromuscular Blockade
An extra bolus of rocuronium after intubation followed by infusion
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.
|
Group B: Moderate Neuromuscular Blockade
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Group A: Deep Neuromuscular Blockade
An extra bolus of rocuronium after intubation followed by infusion
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.
|
Group B: Moderate Neuromuscular Blockade
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
logistic problems
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 10.2 • n=48 Participants
|
56.6 years
STANDARD_DEVIATION 9.7 • n=48 Participants
|
56.1 years
STANDARD_DEVIATION 9.9 • n=96 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=48 Participants
|
24 Participants
n=48 Participants
|
51 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=48 Participants
|
24 Participants
n=48 Participants
|
45 Participants
n=96 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
26.7 kg/m2
STANDARD_DEVIATION 2.9 • n=48 Participants
|
26.5 kg/m2
STANDARD_DEVIATION 3.0 • n=48 Participants
|
26.6 kg/m2
STANDARD_DEVIATION 3.0 • n=96 Participants
|
|
Centre
Radboud
|
35 Participants
n=48 Participants
|
38 Participants
n=48 Participants
|
73 Participants
n=96 Participants
|
|
Centre
LUMC
|
13 Participants
n=48 Participants
|
10 Participants
n=48 Participants
|
23 Participants
n=96 Participants
|
|
Previous abdominal surgery
|
13 Participants
n=48 Participants
|
10 Participants
n=48 Participants
|
23 Participants
n=96 Participants
|
|
Previous pregnancies
|
21 Participants
n=48 Participants
|
21 Participants
n=48 Participants
|
42 Participants
n=96 Participants
|
|
Side of nephrectomy
Left
|
42 Participants
n=48 Participants
|
42 Participants
n=48 Participants
|
84 Participants
n=96 Participants
|
|
Side of nephrectomy
Right
|
6 Participants
n=48 Participants
|
6 Participants
n=48 Participants
|
12 Participants
n=96 Participants
|
|
Vascular anatomy (more than one renel artery or renal vein)
|
13 Participants
n=48 Participants
|
17 Participants
n=48 Participants
|
30 Participants
n=96 Participants
|
PRIMARY outcome
Timeframe: Day 1: 24 hours after detubationPopulation: Explanation of missing data: One patient from group A missed one page of the QOR-40 questionnaire on postoperative day 1. One patient from group B did not complete the questionnaires on postoperative days 1 and 2 because of personal circumstances
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
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=47 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=47 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)
|
169.3 score on a scale
Standard Deviation 18.3
|
169.5 score on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: 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. 1. = extremely poor conditions 2. = poor conditions 3. = acceptable conditions 4. =good conditions 5. = optimal conditions
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Surgical Conditions
|
4.8 score on a scale
Standard Deviation 0.3
|
4.7 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Day 0: once, up to 240 minutesIntraoperative parameter of duration of pneumoperitoneum
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Length of Pneumoperitoneum
|
122.8 minutes
Standard Deviation 44.5
|
113.8 minutes
Standard Deviation 39.2
|
SECONDARY outcome
Timeframe: Day 0: once, up to 240 minutesIntraoperative parameter measuring the time (in minutes) between dissection of the renal artery and flushing of the kidney after retrieval
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Warm Ischemia Time
|
3.6 minutes
Standard Deviation 1.3
|
3.9 minutes
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Day 0: once, up to 240 minutesIntraoperative parameter
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Estimated Blood Loss
|
60.2 ml
Standard Deviation 68.5
|
69.1 ml
Standard Deviation 72.3
|
SECONDARY outcome
Timeframe: Day 0: once, up to 240 minutesNumber of Participants with conversion to open or hand-assisted donor nephrectomy
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Conversion
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 0: once, up to 240 minutesNumber of Participants with Complications which occurred during surgery
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Intra-operative Complications
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 0: once, up to 240 minutesTotal amount of rocuronium administered during surgery
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Cumulative Use of Rocuronium
|
184.6 mg
Standard Deviation 83.1
|
67.0 mg
Standard Deviation 41.2
|
SECONDARY outcome
Timeframe: Day 2: 48 hours after detubationThe 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.
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=47 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Total Score of the Quality of Recovery-40 Questionnaire
|
175.6 score on a scale
Standard Deviation 17.8
|
175.3 score on a scale
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubationPopulation: 1 patient from the moderate NMB group was not able to complete the questionnaires on day 1 and day 2 because of personal circumstances.
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.
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Postoperative Pain
Overall_1h (PACU)
|
4.0 score on a scale
Standard Deviation 2.3
|
4.31 score on a scale
Standard Deviation 2.4
|
|
Postoperative Pain
Referred pain_1h (PACU)
|
0.0 score on a scale
Standard Deviation 0.2
|
0.3 score on a scale
Standard Deviation 1.1
|
|
Postoperative Pain
overall_6h
|
3.7 score on a scale
Standard Deviation 2.7
|
4.5 score on a scale
Standard Deviation 2.2
|
|
Postoperative Pain
Referred pain_6h
|
0.7 score on a scale
Standard Deviation 1.6
|
1.0 score on a scale
Standard Deviation 1.8
|
|
Postoperative Pain
Overall_POD1
|
5.0 score on a scale
Standard Deviation 2.3
|
5.6 score on a scale
Standard Deviation 2.1
|
|
Postoperative Pain
Referred pain+POD1
|
2.5 score on a scale
Standard Deviation 2.7
|
3.2 score on a scale
Standard Deviation 2.8
|
|
Postoperative Pain
Overall_POD2
|
4.6 score on a scale
Standard Deviation 1.9
|
4.9 score on a scale
Standard Deviation 2.2
|
|
Postoperative Pain
Referred pain_POD2
|
2.4 score on a scale
Standard Deviation 2.7
|
3.3 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgeryNumber of participants with postoperative complications that occurred up to 8 weeks after surgery
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Postoperative Complications
during hospital stay
|
2 Participants
|
4 Participants
|
|
Postoperative Complications
30 days after surgery
|
7 Participants
|
5 Participants
|
|
Postoperative Complications
60 days after surgery
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 and 48 hours after detubationScoring 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.
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Discharge Criteria
reached all criteria after 24hours
|
13 Participants
|
15 Participants
|
|
Discharge Criteria
reached all criteria after 48 hours
|
24 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: once, 4 weeks after surgeryTotal amount of pain 4 weeks after surgery Likert scale from 0 to 10. Higher scores represent more pain (worse outcome).
Outcome measures
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 Participants
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 Participants
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Pain Scores
|
1.88 score on a scale
Standard Deviation 1.91
|
1.85 score on a scale
Standard Deviation 1.92
|
Adverse Events
Group A: Deep Neuromuscular Blockade
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group B: Moderate Neuromuscular Blockade
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 participants at risk
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 participants at risk
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/48 • 2 months
|
2.1%
1/48 • Number of events 1 • 2 months
|
Other adverse events
| Measure |
Group A: Deep Neuromuscular Blockade
n=48 participants at risk
An extra bolus of rocuronium after intubation followed by infusion
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 PTC is more than 0 and titrated towards PTC 1-2.
|
Group B: Moderate Neuromuscular Blockade
n=48 participants at risk
Moderate neuromuscular Blockade No additional rocuronium after intubation.
No additional Rocuronium: No additional rocuronium is administered after tracheal intubation.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
12.5%
6/48 • Number of events 6 • 2 months
|
8.3%
4/48 • Number of events 4 • 2 months
|
|
Infections and infestations
Wound infection
|
4.2%
2/48 • Number of events 2 • 2 months
|
0.00%
0/48 • 2 months
|
|
General disorders
Hypertension
|
2.1%
1/48 • Number of events 1 • 2 months
|
2.1%
1/48 • Number of events 1 • 2 months
|
Additional Information
Dr M.C. Warlé
Radboud University Medical Center
Phone: +31-24362415333
Email: Michiel.Warlé@radboudumc.nl
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place