The Difference in Postoperative Cognitive Dysfunction and Myocardial Ischemia Between Propofol and Isoflurane (POCD)
Recruitment status was Not yet recruiting
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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. |
- to evaluate whether there is a difference in the occurrence of POCD [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 |
500 patients older then 65 year, scheduled for elective non-cardiac, non-neuro surgery
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| 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 | |
| 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:
|
Myocardial Ischemia Coronary Artery Disease Ischemia Cognition Disorders Heart Diseases Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Anesthetics Isoflurane Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General |
ClinicalTrials.gov processed this record on May 23, 2013