Trial Outcomes & Findings for Anaesthesia for Laparoscopic Sleeve Gastrectomy (NCT NCT03029715)
NCT ID: NCT03029715
Last Updated: 2020-09-16
Results Overview
Total paracetamol consumption.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Within one hour after surgery
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Intravenous Anaesthesia
Propofol Dexmedetomidine Remifentanil
Propofol: Total intravenous anaesthesia.
Remifentanil: Narcotics
Dexmedetomidine: Total intravenous anaesthesia
|
Inhalation Anaesthesia
Desflurane Remifentanil
Remifentanil: Narcotics
Desflurane: Inhalation anaesthesia.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anaesthesia for Laparoscopic Sleeve Gastrectomy
Baseline characteristics by cohort
| Measure |
Intravenous Anaesthesia
n=50 Participants
Propofol Dexmedetomidine Remifentanil
Propofol: Total intravenous anaesthesia.
Remifentanil: Narcotics
Dexmedetomidine: Total intravenous anaesthesia
|
Inhalation Anaesthesia
n=50 Participants
Desflurane Remifentanil
Remifentanil: Narcotics
Desflurane: Inhalation anaesthesia.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.31 years
STANDARD_DEVIATION 10.43 • n=93 Participants
|
34.35 years
STANDARD_DEVIATION 11.15 • n=4 Participants
|
34.83 years
STANDARD_DEVIATION 10.79 • n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Region of Enrollment
Egypt
|
50 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Within one hour after surgeryTotal paracetamol consumption.
Outcome measures
| Measure |
Sleeve Gastrectomy 1
n=50 Participants
Propofol Dexmedetomidine Remifentanil
Propofol: Total intravenous anaesthesia.
Remifentanil: Narcotics
Dexmedetomidine: Total intravenous anaesthesia
|
Sleeve Gastrectomy 2
n=50 Participants
Desflurane Remifentanil
Remifentanil: Narcotics
Desflurane: Inhalation anaesthesia.
|
|---|---|---|
|
Analgesic Requirements.
|
3.56 mg
Standard Deviation 1.01
|
1.67 mg
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: During operation and follow-up, an average of 2 hoursOutcome measures
| Measure |
Sleeve Gastrectomy 1
n=50 Participants
Propofol Dexmedetomidine Remifentanil
Propofol: Total intravenous anaesthesia.
Remifentanil: Narcotics
Dexmedetomidine: Total intravenous anaesthesia
|
Sleeve Gastrectomy 2
n=50 Participants
Desflurane Remifentanil
Remifentanil: Narcotics
Desflurane: Inhalation anaesthesia.
|
|---|---|---|
|
The Intra-operative Mean Arterial Blood Pressure.
|
71.05 mmHg
Standard Deviation 3.06
|
62.7 mmHg
Standard Deviation 2.98
|
Adverse Events
Intravenous Anaesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inhalation Anaesthesia
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place