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

Cognitive Dysfunction Clinical Trial

— POCD  

Official title:

Postoperative Cognitive Dysfunction and Perioperative Myocardial Ischemia: Comparing Total IV Anesthesia and Inhalation Anesthesia.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00908518
• Other study ID #: TASMC-08-RF-514-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 26, 2009
• Last updated: May 26, 2009
• Start date: June 2009
• Est. completion date: July 2011

Study information

• Verified date: May 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Morbidity
• Cognition Disorders
• Cognitive Dysfunction
• Coronary Artery Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate whether there is a difference in the occurrence of POCD		3 months	No
Secondary	To evaluate whether there is a difference in the occurrence of post-operative cardiac morbidity		3 month	No