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Completed

NCT Number: NCT01000337

Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

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.

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Key information

Conditions

Liver Dysfunction Digestive System Diseases Liver Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aretaieio Hospital, University of Athens

Athens, Attica, 11528, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

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

Other names: Sevorane, 2802252901023,

Propofol

Drug

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

Other names: Lipuro, 2802467102017

Primary outcomes

  1. 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.

Secondary outcomes

  1. Transaminases

    Time frame: February 2011

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

The Impact of Sevoflurane and Propofol Anesthesia on Hepatic Apoptosis Markers

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 23, 2009
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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