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Anesthesia may affect the function of vital organs. Liver is one of them. The investigator's hypothesis is that intravenous or inhalation anesthesia does not impair liver function as assessed by more elegant tests like markers indicating liver apoptosis. In the present randomized prospective trial female patients scheduled for mastectomy or thyroidectomy will receive inhalation or total intravenous anesthesia and markers for liver dysfunction will be determined.
Female patients undergoing mastectomy or thyroidectomy under sevoflurane or propofol anesthesia will be recruited for the study. The type of anesthesia will be determined in a random way using a computer generated table.
All patients will be preoxygenated for 3 minutes before induction of anesthesia. Patients assigned to the sevoflurane group will receive an inhalation induction with sevoflurane via a primed anesthetic circle system and anesthesia will be maintained with sevoflurane. In the propofol group patients anaesthesia will be induced and maintained with propofol.
Blood samples for liver apoptotic markers will be collected before induction of anesthesia, after skin closure as well as 24 and 48 hours postoperatively.
Blood samples will be centrifuged, stored at -80 degrees Celsius and analyzed for M30 and M60 values with radioimmunoassay technique. Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) levels will also be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sevoflurane | Active Comparator | Volatile anesthetic |
|
| Propofol | Active Comparator | Intravenous anesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the M30 and M65 Markers Related to the Anesthesia Type | 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. | preoperatively, end of surgery, 24 and 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Transaminases | February 2011 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Argyro Fassoulaki, MD,PhD,DEAA | Chairman Department of Anesthesiology, Aretaieio Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aretaieio Hospital, University of Athens | Athens | Attica | 11528 | Greece |
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Potential participants prior to group assignment were enrolled but excluded from the trial due to exclusion criteria as defined by the study protocol
The study was conducted between October 2009 and July 2011 in Aretaieo University Hospital, Athens, Greece
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in the M30 and M65 Markers Related to the Anesthesia Type | 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. | 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. | Posted | Mean | Standard Deviation | U/L | preoperatively, end of surgery, 24 and 48 hours postoperatively |
|
Adverse event data were collected during the first 48 hours after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The study was accomplished with no problems leading to data questioning.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Argyro Fassoulaki | Aretaieio Hospital, University of Athens | +30210 7286334 | fassoula@aretaieio.uoa.gr |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Propofol | Drug | Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Transaminases | Not Posted | February 2011 | Participants |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | 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. | 0 | 33 | 0 | 33 |
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| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |