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| Sponsors and Collaborators: |
Mount Sinai School of Medicine National Institute on Aging (NIA) |
|---|---|
| Information provided by: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00507663 |
Purpose
This study proposes a prospective randomized study of elders undergoing elective major abdominal surgery to assess recovery following a unique anesthetic regimen incorporating a adrenergic receptor antagonist. The purposes of this study are to:
| Condition | Intervention | Phase |
|---|---|---|
|
Post Operative Cognitive Dysfunction |
Drug: Tenormin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Estimated Enrollment: | 600 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | August 2008 |
Increasing numbers of aged patients with multiple chronic diseases are undergoing major surgery. In the first third the last century, surgery was considered a desperate measure and patients greater than 50 years of age were felt incapable of sustaining the rigors of an inguinal hernia repair.
Advances in anesthesia during the last century have allowed surgeons to develop an extraordinary array of procedures with excellent outcomes. Over 5.5 million patients aged 60 and over had major procedures in 1994. Centenarians routinely undergo surgical procedures.
Notwithstanding the enthusiasm for surgical treatments, morbidity, mortality, and recovery times for elderly patients are still substantially greater than for younger patients. Some morbidities, such as postoperative delirium and cognitive dysfunction appear to predominantly affect elderly patients.
In a previous study, Dr. Valerie Lawrence, a co-investigator on this proposal, demonstrated that recovery from major surgery, as measured by the ability to accomplish standard activities of daily living, takes an average of 6 weeks while more complicated instrumental activities of daily living take an average of 3 months to return to baseline in elderly surgical patients. These data have profound implications for initiatives to control length of hospital stay, utilization of resources and costs of care. Evidence suggests that family members are requiring extra time off work to care for family members discharged earlier from hospitals. Published reports and our preliminary data support the notion that intraoperative administration of adrenergic receptor antagonists (blockers) will improve functional recovery following surgery under general anesthesia. There is value in targeting functional status for elders undergoing surgery, because there is a direct relationship between functional status and utilization of health resources. Maximizing postoperative recovery, as opposed to minimizing morbidity and mortality, associated with surgical interventions in the elderly is consistent with the goal of prolonging "active life expectancy" expounded by Healthy People 2002.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| The Mayo Clinic | |
| Rochester, Minnesota, United States | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| NYU School of Medicine | |
| New York, New York, United States | |
| Principal Investigator: | Jefrey H. Silverstein, MD | Mount Sinai School of Medicine |
More Information
| Study ID Numbers: | 00-0100, AG018772 |
| Study First Received: | July 25, 2007 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00507663 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Atenolol |
Dementia Cognition Disorders Delirium |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cognition Disorders |