Trial Outcomes & Findings for Surgical Conditions During Laparoscopic Bariatric Surgery (NCT NCT02703909)
NCT ID: NCT02703909
Last Updated: 2018-06-21
Results Overview
The surgeon will grade his satisfaction with the surgical conditions using a 5 point scale with 1 - extremely poor; 2 - poor; 3 - acceptable; 4. good; 5 - optimal surgical conditions
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
144 participants
Primary outcome timeframe
day of surgery
Results posted on
2018-06-21
Participant Flow
Participant milestones
| Measure |
Moderate NMB + 10 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Moderate NMB + 15 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 10 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 15 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
36
|
35
|
|
Overall Study
COMPLETED
|
36
|
37
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgical Conditions During Laparoscopic Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Moderate NMB + 10 mm IP
n=36 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Moderate NMB + 15 mm IP
n=37 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 10 mm IP
n=36 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 15 mm IP
n=35 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 8 • n=5 Participants
|
43 years
STANDARD_DEVIATION 11 • n=7 Participants
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
44 years
STANDARD_DEVIATION 11 • n=4 Participants
|
45 years
STANDARD_DEVIATION 11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
36 participants
n=5 Participants
|
35 participants
n=4 Participants
|
144 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: day of surgeryThe surgeon will grade his satisfaction with the surgical conditions using a 5 point scale with 1 - extremely poor; 2 - poor; 3 - acceptable; 4. good; 5 - optimal surgical conditions
Outcome measures
| Measure |
Moderate NMB + 10 mm IP
n=36 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Moderate NMB + 15 mm IP
n=37 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 10 mm IP
n=36 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 15 mm IP
n=35 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
|---|---|---|---|---|
|
Surgeon Satisfaction Scale
|
2.7 Scores on a scale
Standard Deviation 1.0
|
4.1 Scores on a scale
Standard Deviation 0.9
|
3.1 Scores on a scale
Standard Deviation 1.0
|
4.6 Scores on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: day of surgeryPopulation: The percentage of patients who were able to have their surgery completed at an IP of 10 mm
The patients will be randomized to an initial insufflation pressure of 10 or 15 mm hg. If the surgeons are not satisfied with the initial operating conditions, the insufflating pressure will be increase to 15 mm Hg (if not already at that level). This will be reported as the percentage of patients who were able to have their entire surgery performed at an insufflation pressure of 10 mm Hg.
Outcome measures
| Measure |
Moderate NMB + 10 mm IP
n=36 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Moderate NMB + 15 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 10 mm IP
n=36 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 15 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
|---|---|---|---|---|
|
Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure
|
10 Participants
|
0 Participants
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day of surgery until hospital discharge (approximately 2-3 days)Population: Only 24 of the patients had an IP of 10 mm throughout the surgery. The remainder of the patients either had IP of 15 mm throughout the surgery or were increased to 15 mm at the start of the surgery.
The participants will be given iv fentanyl or hydromorphone after surgery. They will also be given po oxycodone. The investigators will collect data on the amount of opioid that is required after surgery. This will be reported as morphine equivalents using the morphine equivalent calculator at:
Outcome measures
| Measure |
Moderate NMB + 10 mm IP
n=24 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Moderate NMB + 15 mm IP
n=120 Participants
participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 10 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
Deep NMB + 15 mm IP
participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
|
|---|---|---|---|---|
|
Postoperative Opioid Requirement
|
48.8 morphine equivalents
Standard Deviation 26.6
|
56.7 morphine equivalents
Standard Deviation 38.6
|
—
|
—
|
Adverse Events
Moderate NMB + 10 mm IP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate NMB + 15 mm IP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deep NMB + 10 mm IP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deep NMB + 15 mm IP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Terri G. Monk, MD, Principal Investigator
University of Missouri - Columbia
Phone: (573)-882-2568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place