The Difference in Postoperative Cognitive Dysfunction and Myocardial Ischemia Between Propofol and Isoflurane (POCD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Tel Aviv University
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00908518
First received: May 26, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

The progressive aging of the general population cause increase in number of extensive and long surgeries in older patients. Age is a risk factor for perioperative myocardial ischemia and Postoperative Cognitive Dysfunction (POCD) The suggested study will deal with the above-mentioned complication in patients older then 65 years undergoing major non-cardiac surgeries.

It has been shown that Isoflurane and sevoflurane may have a cardio-protective effect after cardiac surgery involving cardio-pulmonary bypass, and it was recommended that isoflurane should be used in these cases. A question was raised but haven't been answered yet, whether this cardio-protective effect exists also in non-cardiac major surgery.

The aim of this study is to evaluate whether there is a difference in the occurrence of postoperative cognitive dysfunction and perioperative myocardial ischemia between total intravenous anesthesia using propofol and isoflurane based anesthesia.


Condition
Cognitive Dysfunction
Cardiac Morbidity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Cognitive Dysfunction and Perioperative Myocardial Ischemia: Comparing Total IV Anesthesia and Inhalation Anesthesia.

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • to evaluate whether there is a difference in the occurrence of POCD [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate whether there is a difference in the occurrence of post-operative cardiac morbidity [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Total Intravenous Anesthesia
Propofol based anesthesia
Inhaled anesthesia
Isoflurane based anesthesia

Detailed Description:

The progressive aging of the general population cause increase in number of extensive and long surgeries in older patients. Age is a risk factor for perioperative myocardial ischemia and Postoperative Cognitive Dysfunction (POCD) The suggested study will deal with the above-mentioned complication in patients older then 65 years undergoing major non-cardiac surgeries.

It has been shown that Isoflurane and sevoflurane may have a cardio-protective effect after cardiac surgery involving cardio-pulmonary bypass, and it was recommended that isoflurane should be used in these cases. A question was raised but haven't been answered yet, whether this cardio-protective effect exists also in non-cardiac major surgery.

The aim of this study is to evaluate whether there is a difference in the occurrence of postoperative cognitive dysfunction and perioperative myocardial ischemia between total intravenous anesthesia using propofol and isoflurane based anesthesia.

The suggested study is a randomized controlled study. 500 patients older then 65 years undergoing elective non-cardiac major surgeries will be studied.

On the day prior to surgery the patient will take a series computerized cognitive tests (Mindstream® cognitive health assessment, neurotrax®, Modiin, Israel). At the holding area before entering the operating room (OR) the patients will be randomly assigned to one of two study groups.

Group 1 -IA: anesthesia will be maintained using Isoflurane carried by O2/air. Group 2 - TIVA : anesthesia will be maintained with propofol. The patients will be followed for 3 months post-operatively. Cognitive function will be assessed 7 days and 3 months postoperatively using computerized tests and telephone interview.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

500 patients older then 65 year, scheduled for elective non-cardiac, non-neuro surgery

Criteria

Inclusion Criteria:

  • Patients that refuse or unable to sign an informed consent

Exclusion Criteria:

  • Patients with any unstable disease
  • Patients treated with medication affecting the nervous system
  • Patients with earring difficulty
  • Patients that will not be able to participate in the study due to language barrier
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908518

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Ron Flaishon, MD    972-52-4266496    flaishon@post.tau.ac.il   
Principal Investigator: Ron Flaishon, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Tel Aviv University
Investigators
Principal Investigator: Ron Flaishon, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Ron Flaishon MD, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00908518     History of Changes
Other Study ID Numbers: TASMC-08-RF-514-CTIL
Study First Received: May 26, 2009
Last Updated: May 26, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Cognitive dysfunction
Cardiac morbidity
anesthesia

Additional relevant MeSH terms:
Cognition Disorders
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Delirium, Dementia, Amnestic, Cognitive Disorders
Heart Diseases
Mental Disorders
Vascular Diseases
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014