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Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

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ClinicalTrials.gov Identifier: NCT01000337
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : September 11, 2012
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Liver Dysfunction
Interventions Drug: Sevoflurane
Drug: Propofol
Enrollment 67
Recruitment Details The study was conducted between October 2009 and July 2011 in Aretaieo University Hospital, Athens, Greece
Pre-assignment Details Potential participants prior to group assignment were enrolled but excluded from the trial due to exclusion criteria as defined by the study protocol
Arm/Group Title Sevoflurane Propofol
Hide Arm/Group Description 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.

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.

Period Title: Overall Study
Started 34 33
Completed 30 30
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             4             3
Arm/Group Title Sevoflurane Propofol Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 34 33 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
 100.0%
33
 100.0%
67
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 67 participants
53.93  (10.19) 48.30  (10.81) 51.1  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
Female
34
 100.0%
33
 100.0%
67
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Greece Number Analyzed 34 participants 33 participants 67 participants
34 33 67
1.Primary Outcome
Title Changes in the M30 and M65 Markers Related to the Anesthesia Type
Hide Description 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.
Time Frame preoperatively, end of surgery, 24 and 48 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sevoflurane Propofol
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 34 33
Mean (Standard Deviation)
Unit of Measure: U/L
M30 marker preoperatively 237.27  (95.46) 279.97  (228.96)
M65 marker preoperatively 427.33  (225.70) 470.30  (261.98)
M30 marker postoperatively 241.83  (108.60) 299.97  (243.85)
M65 marker postoperatively 480.90  (227.51) 478.27  (271.53)
M30 marker 24h postoperatively 231.10  (93.67) 267.17  (197.66)
M65 marker 24h postoperatively 389.17  (158.12) 456.43  (338.91)
M30 marker 48h postoperatively 234.10  (127.27) 254.20  (188.61)
M65 marker 48h postoperatively 404.20  (144.01) 485.53  (272.56)
2.Secondary Outcome
Title Transaminases
Hide Description [Not Specified]
Time Frame February 2011
Outcome Measure Data Not Reported
Time Frame Adverse event data were collected during the first 48 hours after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sevoflurane Propofol
Hide Arm/Group Description 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.

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.

All-Cause Mortality
Sevoflurane Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sevoflurane Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sevoflurane Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/33 (0.00%) 
The study was accomplished with no problems leading to data questioning.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Argyro Fassoulaki
Organization: Aretaieio Hospital, University of Athens
Phone: +30210 7286334
EMail: fassoula@aretaieio.uoa.gr
Layout table for additonal information
Responsible Party: Argyro Fassoulaki, University of Athens
ClinicalTrials.gov Identifier: NCT01000337    
Other Study ID Numbers: Σ-74/07-07-2009
First Submitted: October 22, 2009
First Posted: October 23, 2009
Results First Submitted: May 7, 2012
Results First Posted: September 11, 2012
Last Update Posted: May 19, 2017