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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00908518
Acronym
POCD
Enrollment
500
Registered
2009-05-27
Start date
2009-06-30
Completion date
2011-07-31
Last updated
2009-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Morbidity, Cognitive Dysfunction

Keywords

Cognitive dysfunction, Cardiac morbidity, anesthesia

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.

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.

Interventions

None listed

Sponsors

Tel Aviv University
CollaboratorOTHER
Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
to evaluate whether there is a difference in the occurrence of POCD3 months

Secondary

MeasureTime frame
To evaluate whether there is a difference in the occurrence of post-operative cardiac morbidity3 month

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026