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

NCT00908518 | Unknown DMC

• 1 other identifier: TASMC-08-RF-514-CTIL
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Dysfunction; Cardiac Morbidity

Keywords

Cognitive dysfunction; Cardiac morbidity; anesthesia

Outcome Measures

Primary Outcomes (1)

• to evaluate whether there is a difference in the occurrence of POCD

  3 months

Secondary Outcomes (1)

• To evaluate whether there is a difference in the occurrence of post-operative cardiac morbidity

  3 month

Study Arms (2)

Total Intravenous Anesthesia

Propofol based anesthesia

Inhaled anesthesia

Isoflurane based anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients that refuse or unable to sign an informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ron Flaishon, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: May 27, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: May 27, 2009

Record last verified: 2009-05

Locations

IL (1)