Trial Outcomes & Findings for Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol (NCT NCT01000337)
NCT ID: NCT01000337
Last Updated: 2017-05-19
Results Overview
Blood samples for determination of the markers M30 and M65 as well as the serum transaminases were collected preoperatively, at the end of surgery, 24 and 48 hours postoperatively.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
preoperatively, end of surgery, 24 and 48 hours postoperatively
Results posted on
2017-05-19
Participant Flow
The study was conducted between October 2009 and July 2011 in Aretaieo University Hospital, Athens, Greece
Potential participants prior to group assignment were enrolled but excluded from the trial due to exclusion criteria as defined by the study protocol
Participant milestones
| Measure |
Sevoflurane
Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
|
Propofol
Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.
The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Sevoflurane
Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
|
Propofol
Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.
The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
Baseline characteristics by cohort
| Measure |
Sevoflurane
n=34 Participants
Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
|
Propofol
n=33 Participants
Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.
The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated.
|
Total
n=67 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
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.93 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
48.30 years
STANDARD_DEVIATION 10.81 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: preoperatively, end of surgery, 24 and 48 hours postoperativelyPopulation: For an effect size of 0.20 assuming a two-sided error type I error of 0.05 and a power of 0.80, a sample size of 60 sixty patients (30 patients in each group) would be required.
Blood samples for determination of the markers M30 and M65 as well as the serum transaminases were collected preoperatively, at the end of surgery, 24 and 48 hours postoperatively.
Outcome measures
| Measure |
Sevoflurane
n=34 Participants
Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
|
Propofol
n=33 Participants
Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.
The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated.
|
|---|---|---|
|
Changes in the M30 and M65 Markers Related to the Anesthesia Type
M65 marker preoperatively
|
427.33 U/L
Standard Deviation 225.70
|
470.30 U/L
Standard Deviation 261.98
|
|
Changes in the M30 and M65 Markers Related to the Anesthesia Type
M30 marker preoperatively
|
237.27 U/L
Standard Deviation 95.46
|
279.97 U/L
Standard Deviation 228.96
|
|
Changes in the M30 and M65 Markers Related to the Anesthesia Type
M30 marker postoperatively
|
241.83 U/L
Standard Deviation 108.60
|
299.97 U/L
Standard Deviation 243.85
|
|
Changes in the M30 and M65 Markers Related to the Anesthesia Type
M65 marker postoperatively
|
480.90 U/L
Standard Deviation 227.51
|
478.27 U/L
Standard Deviation 271.53
|
|
Changes in the M30 and M65 Markers Related to the Anesthesia Type
M30 marker 24h postoperatively
|
231.10 U/L
Standard Deviation 93.67
|
267.17 U/L
Standard Deviation 197.66
|
|
Changes in the M30 and M65 Markers Related to the Anesthesia Type
M65 marker 24h postoperatively
|
389.17 U/L
Standard Deviation 158.12
|
456.43 U/L
Standard Deviation 338.91
|
|
Changes in the M30 and M65 Markers Related to the Anesthesia Type
M30 marker 48h postoperatively
|
234.10 U/L
Standard Deviation 127.27
|
254.20 U/L
Standard Deviation 188.61
|
|
Changes in the M30 and M65 Markers Related to the Anesthesia Type
M65 marker 48h postoperatively
|
404.20 U/L
Standard Deviation 144.01
|
485.53 U/L
Standard Deviation 272.56
|
SECONDARY outcome
Timeframe: February 2011Outcome measures
Outcome data not reported
Adverse Events
Sevoflurane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol
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
Argyro Fassoulaki
Aretaieio Hospital, University of Athens
Phone: +30210 7286334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place