Trial Outcomes & Findings for Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure (NCT NCT01722097)
NCT ID: NCT01722097
Last Updated: 2015-10-21
Results Overview
Number of participants with shoulder pain or discomfort (VAS \> 20) in the shoulder region within 14 days after operation. VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
within 14 days
Results posted on
2015-10-21
Participant Flow
Participant milestones
| Measure |
Deep Neuromuscular Blockade
Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium
|
Moderate Neuromuscular Blockade
Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Deep Neuromuscular Blockade
Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium
|
Moderate Neuromuscular Blockade
Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo
|
|---|---|---|
|
Overall Study
Patient sheets not returned
|
6
|
5
|
Baseline Characteristics
Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure
Baseline characteristics by cohort
| Measure |
Deep Neuromuscular Blockade
n=55 Participants
Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium
|
Moderate Neuromuscular Blockade
n=55 Participants
Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 5 • n=5 Participants
|
48 years
STANDARD_DEVIATION 5 • n=7 Participants
|
47 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex/Gender, Customized
women
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
BMI
|
23.1 kg/m^2
STANDARD_DEVIATION 3.0 • n=5 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 3.1 • n=7 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
American Society of Anesthesiologists Physical Status Classification 1
|
52 participants
n=5 Participants
|
49 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Parity (full term pregnancies)
|
2 pregnancies
n=5 Participants
|
2 pregnancies
n=7 Participants
|
2 pregnancies
n=5 Participants
|
|
Previous abdominal surgery
|
26 participants
n=5 Participants
|
35 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Subtotal hysterectomy
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
American Society of Anesthesiologists Physical Status Classification 2
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Total hysterectomy
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 14 daysNumber of participants with shoulder pain or discomfort (VAS \> 20) in the shoulder region within 14 days after operation. VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100).
Outcome measures
| Measure |
Deep Neuromuscular Blockade
n=49 Participants
Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium
|
Moderate Neuromuscular Blockade
n=50 Participants
Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo
|
|---|---|---|
|
Shoulder Pain
|
14 participants
|
30 participants
|
SECONDARY outcome
Timeframe: within 14 daysPain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation. Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation. Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery.
Outcome measures
| Measure |
Deep Neuromuscular Blockade
n=49 Participants
Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium
|
Moderate Neuromuscular Blockade
n=50 Participants
Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo
|
|---|---|---|
|
Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
VAS shoulder pain 4 days AUC
|
16.4 units on a scale*days
Interval 5.8 to 44.7
|
28.5 units on a scale*days
Interval 6.3 to 52.2
|
|
Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
VAS shoulder pain 14 days AUC
|
27.6 units on a scale*days
Interval 8.2 to 67.9
|
36.3 units on a scale*days
Interval 9.7 to 86.6
|
|
Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
VAS incisional pain 4 days AUC
|
88.4 units on a scale*days
Interval 33.8 to 189.3
|
102.2 units on a scale*days
Interval 35.8 to 159.1
|
|
Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
VAS incisional pain 14 days AUC
|
144.6 units on a scale*days
Interval 62.0 to 291.6
|
150.8 units on a scale*days
Interval 56.8 to 306.3
|
|
Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
VAS abdominal pain 4 days AUC
|
102.4 units on a scale*days
Interval 50.0 to 213.2
|
114.1 units on a scale*days
Interval 57.8 to 207.5
|
|
Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
VAS abdominal pain 14 days AUC
|
190.8 units on a scale*days
Interval 103.2 to 366.8
|
215.5 units on a scale*days
Interval 109.5 to 396.3
|
|
Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
VAS overall pain 4 days AUC
|
101.7 units on a scale*days
Interval 51.9 to 200.8
|
129.8 units on a scale*days
Interval 79.0 to 198.1
|
|
Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
VAS overall pain 14 days AUC
|
190.2 units on a scale*days
Interval 118.9 to 402.5
|
256.9 units on a scale*days
Interval 121.3 to 403.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During surgeryNumber of unintended and unwanted patient-movements registered by the surgeon
Outcome measures
Outcome data not reported
Adverse Events
Deep Neuromuscular Blockade
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Neuromuscular Blockade
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deep Neuromuscular Blockade
n=55 participants at risk
Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
Rocuronium
|
Moderate Neuromuscular Blockade
n=55 participants at risk
Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo
|
|---|---|---|
|
Infections and infestations
Infection after surgery
|
3.6%
2/55 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Renal and urinary disorders
Lesion of the bladder
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Renal and urinary disorders
Vesicovaginal fistula
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Surgical and medical procedures
Postoperative bleeding
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Surgical and medical procedures
hematoma
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Matias Vested Madsen
Herlev Hospital, University of Copenhagen, Department of Anaesthesiology
Phone: +45 38683868
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place