Elder Surgery - Functional Recovery Following Beta Blockade
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|ClinicalTrials.gov Identifier: NCT00507663|
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : March 16, 2016
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:
- to determine if using atenolol, a beta-blocker drug commonly used to treat high blood pressure and heart disease, as part of your anesthetic regimen will decrease complications that sometimes occur in elderly patients who are undergoing surgery and being given anesthesia.
- to see if it improves or quickens your recovery from anesthesia and surgery.
- to help investigators design better ways to administer anesthesia during surgery, especially in elderly patients, so that the complications and the time to recover from surgery and anesthesia can be decreased.
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Cognitive Dysfunction||Drug: Atenolol||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||359 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Elder Surgery - Functional Recovery Following Beta Blockade|
|Study Start Date :||September 2002|
|Primary Completion Date :||November 2007|
|Study Completion Date :||November 2007|
Atenolol given prior to and for up to 7 days after surgery
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.
Other Name: Tenormin
No Intervention: routine care
routine clinical care
- Long Term Functional Recovery [ Time Frame: at 3 weeks after surgery ]self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).
- Timed Up and Go test [ Time Frame: preoperatively ]assesses basic functional mobility
- Timed Up and Go test [ Time Frame: once at 7-10 days postoperatively ]assesses basic functional mobility
- Timed Up and Go test [ Time Frame: 1 month postoperatively ]assesses basic functional mobility
- Timed Up and Go test [ Time Frame: 3 months postoperatively ]assesses basic functional mobility
- Timed Up and Go test [ Time Frame: 6 months postoperatively ]assesses basic functional mobility
- Hand grip strength [ Time Frame: preoperatively ]performance-based measure of upper extremity strength.
- Hand grip strength [ Time Frame: once at 7-10 days postoperatively ]performance-based measure of upper extremity strength.
- Hand grip strength [ Time Frame: 1 month postoperatively ]performance-based measure of upper extremity strength.
- Hand grip strength [ Time Frame: 3 months postoperatively ]performance-based measure of upper extremity strength.
- Hand grip strength [ Time Frame: 6 months postoperatively ]performance-based measure of upper extremity strength.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507663
|United States, Minnesota|
|The Mayo Clinic|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10016|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Jefrey H. Silverstein, MD||Icahn School of Medicine at Mount Sinai|