Clinical trial NCT00507663: Elder Surgery - Functional Recovery Following Beta Blockade
Official title: Elder Surgery - Functional Recovery Following Beta Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Cognitive Dysfunction
Keywords: beta blocker
functional recovery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2007-07-26
Enrollment: 359
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. 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.
2. to see if it improves or quickens your recovery from anesthesia and surgery.
3. 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.

Detailed description: 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 criteria: Inclusion Criteria:

* Patients 65 years of age or older
* Patients undergoing elective major abdominal surgery (including but not limited to bowel, gastric, esophageal, pancreatic, gynecologic, urologic, and major intra-abdominal vascular procedures).
* Procedures requiring general anesthesia
* Laparoscopic-assisted major abdominal procedures
* Procedures requiring a 2-3 day postoperative stay will be included.

Exclusion Criteria:

* Unable to give informed consent to participate
* Folstein Mini-Mental State Examination Score \< 17
* Gastrostomy tube placement
* Laparoscopic cholecystectomy, laparoscopic Nissen fundoplication, or any type of Hernia repair
* Appendectomy
* Emergency surgery
* Contraindications to adrenergic antagonists (third-degree heart block, decompensated congestive heart failure, active bronchospasm)
* Surgery within the previous month
* Major systemic infections
* Allergies to or incompatibilities with any drug used in this study
* Principle language other than English or Spanish
* Residence greater than 100 miles away from Manhattan
* Chronic debilitated state from which significant functional improvement following surgery is not anticipated (e.g., some nursing home residents, known metastatic cancer with poor prognosis)
* Chronic opioid usage
* Immunosuppression (subsequent opportunistic infections may obscure postoperative recovery).

Primary outcomes:
measure: Long Term Functional Recovery
timeFrame: at 3 weeks after surgery
Secondary outcomes:
measure: Timed Up and Go test
timeFrame: preoperatively
measure: Timed Up and Go test
timeFrame: once at 7-10 days postoperatively
measure: Timed Up and Go test
timeFrame: 1 month postoperatively
measure: Timed Up and Go test
timeFrame: 3 months postoperatively
measure: Timed Up and Go test
timeFrame: 6 months postoperatively
measure: Hand grip strength
timeFrame: preoperatively
measure: Hand grip strength
timeFrame: once at 7-10 days postoperatively
measure: Hand grip strength
timeFrame: 1 month postoperatively
measure: Hand grip strength
timeFrame: 3 months postoperatively
measure: Hand grip strength
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Rochester
country: United States
facility: The Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jefrey H. Silverstein, MD
role: PRINCIPAL_INVESTIGATOR
References: