An interventional study of Sevoflurane and Propofol in Liver Dysfunction, sponsored by University of Athens. Completed at 1 site in Greece. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by University of Athens · Not applicable, Interventional, and Other
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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This study's enrollment of 67 is above the median of 50 across 1,328 interventional studies indexed under Liver Diseases.
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Exclusion Criteria:
Volatile anesthetic
Drug: Sevoflurane
Intravenous anesthetic
Drug: Propofol
Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
Also known as: Sevorane, 2802252901023,
Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h
Also known as: Lipuro, 2802467102017
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
Transaminases
Time frame: February 2011
The study was conducted between October 2009 and July 2011 in Aretaieo University Hospital, Athens, Greece
| Milestone | Sevoflurane | Propofol |
|---|---|---|
| Started | 34 | 33 |
| Completed | 30 | 30 |
| Not completed | 4 | 3 |
| Withdrew: Lost to follow-up | 4 | 3 |
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.
| U/L | Sevoflurane | Propofol |
|---|---|---|
| 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 |
Results for this outcome have not been posted.
Collected over Adverse event data were collected during the first 48 hours after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sevoflurane | — | 0/34 (0%) | 0/34 (0%) |
| Propofol | — | 0/33 (0%) | 0/33 (0%) |
| Age, Categorical(Participants) | Sevoflurane | Propofol | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 33 | 67 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Sevoflurane | Propofol | Total |
|---|---|---|---|
| Mean | 53.93 ± 10.19 | 48.30 ± 10.81 | 51.1 ± 10.7 |
| Sex: Female, Male(Participants) | Sevoflurane | Propofol | Total |
|---|---|---|---|
| Female | 34 | 33 | 67 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sevoflurane | Propofol | Total |
|---|---|---|---|
| Greece | 34 | 33 | 67 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Oct 2009, a primary completion of Nov 2011 and a completion of Apr 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2012, 10 months after primary completion.
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sevoflurane · Propofol