Liver Dysfunction
Conditions
Keywords
Liver Apoptosis
Brief summary
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.
Detailed description
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.
Interventions
DRUGSevoflurane
Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
DRUGPropofol
Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer
Exclusion criteria
* Drug intake which may affect liver function * Severe cardiovascular or respiratory disease * Hepatic or renal dysfunction * Pregnancy * Alcohol and drug abuse * Body Mass Index (BMI) \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the M30 and M65 Markers Related to the Anesthesia Type | preoperatively, end of surgery, 24 and 48 hours postoperatively | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Transaminases | February 2011 |
Countries
Greece
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 33 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
Baseline characteristics
| Characteristic | Propofol | Sevoflurane | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 34 Participants | 67 Participants |
| Age, Continuous | 48.30 years STANDARD_DEVIATION 10.81 | 53.93 years STANDARD_DEVIATION 10.19 | 51.1 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Greece | 33 participants | 34 participants | 67 participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 |
Outcome results
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.
Time frame: preoperatively, end of surgery, 24 and 48 hours postoperatively
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sevoflurane | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M30 marker preoperatively | 237.27 U/L | Standard Deviation 95.46 |
| Sevoflurane | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M65 marker preoperatively | 427.33 U/L | Standard Deviation 225.7 |
| Sevoflurane | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M30 marker postoperatively | 241.83 U/L | Standard Deviation 108.6 |
| Sevoflurane | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M65 marker postoperatively | 480.90 U/L | Standard Deviation 227.51 |
| Sevoflurane | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M30 marker 24h postoperatively | 231.10 U/L | Standard Deviation 93.67 |
| Sevoflurane | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M65 marker 24h postoperatively | 389.17 U/L | Standard Deviation 158.12 |
| Sevoflurane | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M30 marker 48h postoperatively | 234.10 U/L | Standard Deviation 127.27 |
| Sevoflurane | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M65 marker 48h postoperatively | 404.20 U/L | Standard Deviation 144.01 |
| Propofol | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M65 marker 48h postoperatively | 485.53 U/L | Standard Deviation 272.56 |
| Propofol | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M30 marker preoperatively | 279.97 U/L | Standard Deviation 228.96 |
| Propofol | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M30 marker 24h postoperatively | 267.17 U/L | Standard Deviation 197.66 |
| Propofol | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M65 marker preoperatively | 470.30 U/L | Standard Deviation 261.98 |
| Propofol | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M30 marker 48h postoperatively | 254.20 U/L | Standard Deviation 188.61 |
| Propofol | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M30 marker postoperatively | 299.97 U/L | Standard Deviation 243.85 |
| Propofol | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M65 marker 24h postoperatively | 456.43 U/L | Standard Deviation 338.91 |
| Propofol | Changes in the M30 and M65 Markers Related to the Anesthesia Type | M65 marker postoperatively | 478.27 U/L | Standard Deviation 271.53 |
Secondary
Transaminases
Time frame: February 2011