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| ID | Type | Description | Link |
|---|---|---|---|
| AG018772 | Other Grant/Funding Number | National Institute on Aging (NIA) |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atenolol | Experimental | Atenolol given prior to and for up to 7 days after surgery |
|
| routine care | No Intervention | routine clinical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atenolol | Drug | Patients with a standing prescription for β-blockers will be continued on that medication. Pts not currently receiving a beta blocker will be given 50mg of atenolol on the morning of surgery, 50-100mg, twice per day, on the first postoperative day until postoperative day 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Functional Recovery | self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL). | at 3 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go test | assesses basic functional mobility | preoperatively |
| Timed Up and Go test | assesses basic functional mobility | once at 7-10 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jefrey H. Silverstein, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| NYU School of Medicine |
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| ID | Term |
|---|---|
| D001262 | Atenolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Timed Up and Go test | assesses basic functional mobility | 1 month postoperatively |
| Timed Up and Go test | assesses basic functional mobility | 3 months postoperatively |
| Timed Up and Go test | assesses basic functional mobility | 6 months postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | preoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | once at 7-10 days postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | 1 month postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | 3 months postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | 6 months postoperatively |
| New York |
| New York |
| 10016 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |