Title

Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol
The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers
  • Phase

    N/A
  • Study Type

    Interventional
  • Study Participants

    67
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.
Study Started
Oct 31
2009
Primary Completion
Nov 30
2011
Study Completion
Apr 30
2012
Results Posted
Sep 11
2012
Estimate
Last Update
May 19
2017

Drug Sevoflurane

Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.

  • Other names: Sevorane, 2802252901023,

Drug Propofol

Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h

  • Other names: Lipuro, 2802467102017

sevoflurane Active Comparator

Volatile anesthetic

Propofol Active Comparator

Intravenous anesthetic

Criteria

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

Summary

Sevoflurane

Propofol

All Events

Event Type Organ System Event Term

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.

Sevoflurane

M30 marker 24h postoperatively

231.1
U/L (Mean)
Standard Deviation: 93.67

M30 marker 48h postoperatively

234.1
U/L (Mean)
Standard Deviation: 127.27

M30 marker postoperatively

241.83
U/L (Mean)
Standard Deviation: 108.60

M30 marker preoperatively

237.27
U/L (Mean)
Standard Deviation: 95.46

M65 marker 24h postoperatively

389.17
U/L (Mean)
Standard Deviation: 158.12

M65 marker 48h postoperatively

404.2
U/L (Mean)
Standard Deviation: 144.01

M65 marker postoperatively

480.9
U/L (Mean)
Standard Deviation: 227.51

M65 marker preoperatively

427.33
U/L (Mean)
Standard Deviation: 225.70

Propofol

M30 marker 24h postoperatively

267.17
U/L (Mean)
Standard Deviation: 197.66

M30 marker 48h postoperatively

254.2
U/L (Mean)
Standard Deviation: 188.61

M30 marker postoperatively

299.97
U/L (Mean)
Standard Deviation: 243.85

M30 marker preoperatively

279.97
U/L (Mean)
Standard Deviation: 228.96

M65 marker 24h postoperatively

456.43
U/L (Mean)
Standard Deviation: 338.91

M65 marker 48h postoperatively

485.53
U/L (Mean)
Standard Deviation: 272.56

M65 marker postoperatively

478.27
U/L (Mean)
Standard Deviation: 271.53

M65 marker preoperatively

470.3
U/L (Mean)
Standard Deviation: 261.98

Transaminases

Outcome Measure Data Not Reported

Total

67
Participants

Age, Continuous

51.1
years (Mean)
Standard Deviation: 10.7

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Sevoflurane

Propofol

Drop/Withdrawal Reasons

Sevoflurane

Propofol