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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognitive Dysfunction Cardiac Morbidity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Total Intravenous Anesthesia

Propofol based anesthesia

No interventions assigned to this group

Inhaled anesthesia

Isoflurane based anesthesia

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No