Elder Surgery - Functional Recovery Following Beta Blockade

Post Operative Cognitive Dysfunction Clinical Trial

Official title: Elder Surgery - Functional Recovery Following Beta Blockade

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Post Operative Cognitive Dysfunction

• NCT number: NCT00507663
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: Phase 4
• Start date: September 2002
• Completion date: November 2007