Trial Outcomes & Findings for Effect of Deep Neuromuscular Block (NMB), Inhalation or TIVA on Pneumoperitoneum. (NCT NCT01930747)
NCT ID: NCT01930747
Last Updated: 2019-05-29
Results Overview
the impact of the following agents on the pressure at zero volume (PV0): remifentanyl \> 0.50 µg/kg/min; sevoflurane 1 MAC and deep neuromuscular block (rocuronium given with PTC \< 4).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
5 min after reaching 1 MAC or haven given the anesthetics intravenous
Results posted on
2019-05-29
Participant Flow
study is performed in operating theatre of one center: and one campus: campus Brugge, center: AZ SINT JAN Brugge-Oostende. study is performed on patients requiring laparoscopy for bariatric surgery.
8 patients were excluded from randomization due to movements and impossibility to measure abdominal compliance before randomization.
Participant milestones
| Measure |
Deep Neuromuscular Block
deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given
rocuronium: measure effect on laparoscopic workspace
|
Inhalation With 1 MAC Sevoflurane
1 MAC Sevoflurane inhalation is given after first measurement of lap workspace
Sevoflurane: 1 MAC sevoflurane inhalation is given
|
Remifentanyl
remifentanyl infusion is given after first measurement of lap workspace
remifentanyl: remifentanyl is given in infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
12
|
|
Overall Study
COMPLETED
|
16
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Deep Neuromuscular Block (NMB), Inhalation or TIVA on Pneumoperitoneum.
Baseline characteristics by cohort
| Measure |
Deep Neuromuscular Block
n=16 Participants
deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given
rocuronium: measure effect on laparoscopic workspace
|
Inhalation With 1 MAC Sevoflurane
n=14 Participants
1 MAC Sevoflurane inhalation is given after first measurement of lap workspace
Sevoflurane: 1 MAC sevoflurane inhalation is given
|
Remifentanyl
n=12 Participants
remifentanyl infusion is given after first measurement of lap workspace
remifentanyl: remifentanyl is given in infusion
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
38.93 years
STANDARD_DEVIATION 5.54 • n=99 Participants
|
36.5 years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
40.67 years
STANDARD_DEVIATION 7.33 • n=206 Participants
|
38.61 years
STANDARD_DEVIATION 12.11 • n=7 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
16 participants
n=99 Participants
|
14 participants
n=107 Participants
|
12 participants
n=206 Participants
|
42 participants
n=7 Participants
|
|
Elastance
|
2.66 mmHg/Liter
STANDARD_DEVIATION 1.38 • n=99 Participants
|
2.57 mmHg/Liter
STANDARD_DEVIATION 1.44 • n=107 Participants
|
2.58 mmHg/Liter
STANDARD_DEVIATION 1.0 • n=206 Participants
|
2.61 mmHg/Liter
STANDARD_DEVIATION 1.05 • n=7 Participants
|
|
PV0
|
7.3 mmHg
STANDARD_DEVIATION 3.37 • n=99 Participants
|
7.9 mmHg
STANDARD_DEVIATION 3.37 • n=107 Participants
|
6.5 mmHg
STANDARD_DEVIATION 1.5 • n=206 Participants
|
7.4 mmHg
STANDARD_DEVIATION 3.1 • n=7 Participants
|
PRIMARY outcome
Timeframe: 5 min after reaching 1 MAC or haven given the anesthetics intravenousPopulation: laparoscopic bariatric surgery population
the impact of the following agents on the pressure at zero volume (PV0): remifentanyl \> 0.50 µg/kg/min; sevoflurane 1 MAC and deep neuromuscular block (rocuronium given with PTC \< 4).
Outcome measures
| Measure |
Deep Neuromuscular Block
n=16 Participants
deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given
rocuronium: measure effect on laparoscopic workspace
|
Inhalation With 1 MAC Sevoflurane
n=14 Participants
1 MAC Sevoflurane inhalation is given after first measurement of lap workspace
Sevoflurane: 1 MAC sevoflurane inhalation is given
|
Remifentanyl
n=12 Participants
remifentanyl infusion is given after first measurement of lap workspace
remifentanyl: remifentanyl is given in infusion
|
|---|---|---|---|
|
Effect of Anesthetics on the Pressure at Zero Volume (PV0) Measured During Insufflation of the Abdomen
|
5.7 mmHg
Standard Deviation 1
|
8.29 mmHg
Standard Deviation 3.6
|
6.58 mmHg
Standard Deviation 1.39
|
PRIMARY outcome
Timeframe: 5 min after reaching 1 MAC or haven given the anesthetics intravenousPopulation: laparoscopic bariatric surgery population
the impact of the following agents on the abdominal elastance (E) : remifentanyl \> 0.50 µg/kg/min; sevoflurane 1 MAC and deep neuromuscular block (rocuronium given with PTC \< 4).
Outcome measures
| Measure |
Deep Neuromuscular Block
n=16 Participants
deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given
rocuronium: measure effect on laparoscopic workspace
|
Inhalation With 1 MAC Sevoflurane
n=14 Participants
1 MAC Sevoflurane inhalation is given after first measurement of lap workspace
Sevoflurane: 1 MAC sevoflurane inhalation is given
|
Remifentanyl
n=12 Participants
remifentanyl infusion is given after first measurement of lap workspace
remifentanyl: remifentanyl is given in infusion
|
|---|---|---|---|
|
Effect of Anesthetics on the Abdominal Elastance (E) Measured During Insufflation of the Abdomen by
|
2.53 mmHg/liter
Standard Deviation 1.23
|
2.71 mmHg/liter
Standard Deviation 1.44
|
2.5 mmHg/liter
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: from zero till 24 hours after recovery of surgery.To compare the major adverse events among the patient groups who receive the different agents listed above in the "primary efficacy objective"
Outcome measures
| Measure |
Deep Neuromuscular Block
n=16 Participants
deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given
rocuronium: measure effect on laparoscopic workspace
|
Inhalation With 1 MAC Sevoflurane
n=14 Participants
1 MAC Sevoflurane inhalation is given after first measurement of lap workspace
Sevoflurane: 1 MAC sevoflurane inhalation is given
|
Remifentanyl
n=12 Participants
remifentanyl infusion is given after first measurement of lap workspace
remifentanyl: remifentanyl is given in infusion
|
|---|---|---|---|
|
Adverse Events Difference Between the Three Groups
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Deep Neuromuscular Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inhalation With 1 MAC Sevoflurane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Remifentanyl
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deep Neuromuscular Block
n=16 participants at risk
deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given
rocuronium: measure effect on laparoscopic workspace
|
Inhalation With 1 MAC Sevoflurane
n=14 participants at risk
1 MAC Sevoflurane inhalation is given after first measurement of lap workspace
Sevoflurane: 1 MAC sevoflurane inhalation is given
|
Remifentanyl
n=12 participants at risk
remifentanyl infusion is given after first measurement of lap workspace
remifentanyl: remifentanyl is given in infusion
|
|---|---|---|---|
|
Blood and lymphatic system disorders
post operative bleeding
|
0.00%
0/16 • one month post operative
|
0.00%
0/14 • one month post operative
|
8.3%
1/12 • Number of events 1 • one month post operative
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place