Trial Outcomes & Findings for Study of Anaesthesia Costs and Recovery Profiles (NCT NCT02920749)
NCT ID: NCT02920749
Last Updated: 2018-02-06
Results Overview
drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
at induction one dose and during anaesthesia mg/1 hour
Results posted on
2018-02-06
Participant Flow
In this study we compared the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anaesthesia with controlled hypotension for otorhinolaryngeal surgery.
We studied patients with ASA physical status I or II, their age between was between 18 and 65 years. Individuals with a history of pulmonary, psychiatric, cerebrovascular or congenital neuromuscular disease were excluded from the study. Patients were blocked randomised to one of four anaesthetic treatment groups with closed envelops.
Participant milestones
| Measure |
Group A
Anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane and fentanyl dosing was adjusted for the same MAP range for controlled hypotension within 60-85 mmHg. Atracurium was administered at regular intervals.
|
Group B
In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Sevoflurane and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
|
Group C
Anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol and fentanyl dosing was adjusted for the same MAP range. Atracurium was administered at regular intervals.
|
Group D
In this group anaesthesia was maintained with propofol. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Propofol and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Anaesthesia Costs and Recovery Profiles
Baseline characteristics by cohort
| Measure |
Group A
n=30 Participants
General anaesthesia was maintained with sevoflurane.
|
Group B
n=30 Participants
Anaesthesia was maintained with sevoflurane and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
|
Group C
n=30 Participants
General anaesthesia was maintained with propofol.
|
Group D
n=30 Participants
Anaesthesia was maintained with propofol and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
30 participants
n=4 Participants
|
120 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: at induction one dose and during anaesthesia mg/1 hourdrugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams
Outcome measures
| Measure |
Group A
n=30 Participants
Fentanyl consumption was studied during sevoflurane anaesthesia. It was registered in milligram.
|
Group B
n=30 Participants
Fentanyl consumption was studied during sevoflurane anaesthesia with BIS and TOF monitoring. It was registered in milligram.
.
|
Group C
n=30 Participants
Fentanyl consumption was studied during total intravenous anaesthesia. It was registered in milligram.
|
Group D
n=30 Participants
Fentanyl consumption was studied during total intravenous anaesthesia with BIS and TOF monitoring. It was registered in milligram.
|
|---|---|---|---|---|
|
Drug Consumption
fentanyl at induction
|
0.0983 mg
Standard Deviation 0.0091
|
0.1033 mg
Standard Deviation 0.0183
|
0.0991 mg
Standard Deviation 0.0046
|
0.0992 mg
Standard Deviation 0.0103
|
|
Drug Consumption
propofol at induction
|
196.3 mg
Standard Deviation 46.9
|
166.4 mg
Standard Deviation 35.2
|
194.3 mg
Standard Deviation 18.9
|
147.3 mg
Standard Deviation 30.2
|
|
Drug Consumption
atracurium at induction
|
38.3 mg
Standard Deviation 4.2
|
37.3 mg
Standard Deviation 6.7
|
36.0 mg
Standard Deviation 5.7
|
37.7 mg
Standard Deviation 7.0
|
|
Drug Consumption
fentanyl during anaesthesia
|
0.0546 mg
Standard Deviation 0.0269
|
0.0598 mg
Standard Deviation 0.0389
|
0.0898 mg
Standard Deviation 0,0428
|
0.0947 mg
Standard Deviation 0.0340
|
|
Drug Consumption
sevoflurane during anesthesia
|
11400 mg
Standard Deviation 2800
|
14800 mg
Standard Deviation 12400
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Drug Consumption
propofol during anesthesia
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
1185.5 mg
Standard Deviation 320.9
|
1082.1 mg
Standard Deviation 297.9
|
|
Drug Consumption
atracurium during anaesthesia
|
8.3 mg
Standard Deviation 3.7
|
7.4 mg
Standard Deviation 4.7
|
8.5 mg
Standard Deviation 4.7
|
8.9 mg
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 1 hourtotal cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros
Outcome measures
| Measure |
Group A
n=30 total cost of anaesthesia
Fentanyl consumption was studied during sevoflurane anaesthesia. It was registered in milligram.
|
Group B
n=30 total cost of anaesthesia
Fentanyl consumption was studied during sevoflurane anaesthesia with BIS and TOF monitoring. It was registered in milligram.
.
|
Group C
n=30 total cost of anaesthesia
Fentanyl consumption was studied during total intravenous anaesthesia. It was registered in milligram.
|
Group D
n=30 total cost of anaesthesia
Fentanyl consumption was studied during total intravenous anaesthesia with BIS and TOF monitoring. It was registered in milligram.
|
|---|---|---|---|---|
|
Costs of Anaesthesia
total drug cost
|
8.84 euros
Standard Deviation 4.11
|
7.86 euros
Standard Deviation 3.54
|
8.33 euros
Standard Deviation 3.02
|
7.52 euros
Standard Deviation 2.49
|
|
Costs of Anaesthesia
total disposable cost
|
6.49 euros
Standard Deviation 0.11
|
23.25 euros
Standard Deviation 0.12
|
8.09 euros
Standard Deviation 0.07
|
24.76 euros
Standard Deviation 0.19
|
|
Costs of Anaesthesia
total cost of anaesthesia
|
12.15 euros
Standard Deviation 5.32
|
19.95 euros
Standard Deviation 8.53
|
13.23 euros
Standard Deviation 4.23
|
22.11 euros
Standard Deviation 8.08
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=30 participants at risk
Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.
Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
|
Group B
n=30 participants at risk
Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.
Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
.
|
Group C
n=30 participants at risk
During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
|
Group D
n=30 participants at risk
During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
vomiting
|
3.3%
1/30 • 2 years
|
6.7%
2/30 • 2 years
|
3.3%
1/30 • 2 years
|
3.3%
1/30 • 2 years
|
|
Cardiac disorders
other minor complications of anaesthesia
|
43.3%
13/30 • 2 years
|
43.3%
13/30 • 2 years
|
10.0%
3/30 • 2 years
|
23.3%
7/30 • 2 years
|
Additional Information
Dr. Timea Bocskai
Department of Anaesthesiology and Intensive Therapy, University of Pecs
Phone: 36 72 507374
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place