Liver DysfunctionNCT01000337

Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

A study testing Sevoflurane and Propofol in people with Liver Dysfunction, run by University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 to 65 years, women only
Conditions the study is for: Liver Dysfunction
What is being tested?: Sevoflurane and Propofol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteGreece
Study dates: Oct 2009to Apr 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

Aretaieio Hospital, University of Athens
Athens, Attica, 11528

Other trials in Greece

About this study

Official title: The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers

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.

Read the 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.

Conditions: Liver Dysfunction
Being tested: Sevoflurane, Propofol
Keywords: Liver Apoptosis
Medical subject headings: Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SevofluraneDrug
Also called Sevorane, 2802252901023,
Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.
PropofolDrug
Also called Lipuro, 2802467102017
Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h

Study groups in NCT01000337
Study group	Role	What they receive
sevoflurane	Active comparator	Volatile anesthetic Receives: Drug: Sevoflurane
Propofol	Active comparator	Intravenous anesthetic Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: preoperatively, end of surgery, 24 and 48 hours postoperatively

Secondary outcomes (1)

Transaminases
Measured: February 2011

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Apr 2012

First posted23 Oct 2009 (estimated)
Study startOct 2009
Primary completionNov 2011
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01000337
Sponsor's protocol ID: Σ-74/07-07-2009
Status last verified: Apr 2017
First submitted: 22 Oct 2009
Last updated: 19 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

All Liver Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers
ClinicalTrials.gov ID: NCT01000337
Acronym / sponsor ID: Σ-74/07-07-2009
Conditions: Liver Dysfunction
Keywords: Liver Apoptosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: University of AthensUniversity, hospital or other
Study start: Oct 2009
Primary completion: Nov 2011 (actual)
Study completion: Apr 2012 (actual)
First posted: 23 Oct 2009 (estimated)
Results: Posted 11 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Blood samples for liver apoptotic markers will be collected before induction of anesthesia, after skin closure as well as 24 and 48 hours postoperatively.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
sevoflurane	Active comparator	Drug: SevofluraneVolatile anesthetic
Propofol	Active comparator	Drug: PropofolIntravenous anesthetic

Who may qualify

Ages: 30 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer

Key exclusion criteria (6 listed)

Drug intake which may affect liver function
Severe cardiovascular or respiratory disease
Hepatic or renal dysfunction
Pregnancy
Alcohol and drug abuse

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SevofluraneAlso: Sevorane, 2802252901023,Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%.	Drug	sevoflurane
PropofolAlso: Lipuro, 2802467102017Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h	Drug	Propofol

Primary outcome

Changes in the M30 and M65 Markers Related to the Anesthesia Type
Time frame: 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.

1 secondary outcome

Transaminases
Time frame: February 2011

Results and safety

Results posted to the registry on 11 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sevoflurane	34	30
Propofol	33	30

Primary outcome: Changes in the M30 and M65 Markers Related to the Anesthesia Type

Time frame: preoperatively, end of surgery, 24 and 48 hours postoperatively. Mean (Standard Deviation). Unit: U/L

Measure	Sevoflurane n = 34	Propofol n = 33
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)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the first 48 hours after surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sevoflurane	0 of 34 (0%)	0 of 34 (0%)	Not reported
Propofol	0 of 33 (0%)	0 of 33 (0%)	Not reported

Limitations and caveats (from the sponsor): The study was accomplished with no problems leading to data questioning.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Liver Dysfunction

Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Argyro Fassoulaki, MD,PhD,DEAA study chair

Chairman Department of Anesthesiology, Aretaieio Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sevoflurane and Propofol in people with Liver Dysfunction, run by University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the M30 and M65 Markers Related to the Anesthesia Type (time frame: preoperatively, end of surgery, 24 and 48 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01000337.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.