Elder Surgery - Functional Recovery Following Beta Blockade

Post Operative Cognitive Dysfunction Clinical Trial

Official title:

Elder Surgery - Functional Recovery Following Beta Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507663
• Other study ID #: GCO 00-0100
• Secondary ID: AG018772
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2007
• Last updated: March 14, 2016
• Start date: September 2002
• Est. completion date: November 2007

Study information

• Verified date: March 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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).

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

Intervention

Drug:
• Atenolol
Patients with a standing prescription for ß-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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYU School of Medicine	New York	New York
United States	The Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long Term Functional Recovery	self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).	at 3 weeks after surgery	No
Secondary	Timed Up and Go test	assesses basic functional mobility	preoperatively	No
Secondary	Timed Up and Go test	assesses basic functional mobility	once at 7-10 days postoperatively	No
Secondary	Timed Up and Go test	assesses basic functional mobility	1 month postoperatively	No
Secondary	Timed Up and Go test	assesses basic functional mobility	3 months postoperatively	No
Secondary	Timed Up and Go test	assesses basic functional mobility	6 months postoperatively	No
Secondary	Hand grip strength	performance-based measure of upper extremity strength.	preoperatively	No
Secondary	Hand grip strength	performance-based measure of upper extremity strength.	once at 7-10 days postoperatively	No
Secondary	Hand grip strength	performance-based measure of upper extremity strength.	1 month postoperatively	No
Secondary	Hand grip strength	performance-based measure of upper extremity strength.	3 months postoperatively	No
Secondary	Hand grip strength	performance-based measure of upper extremity strength.	6 months postoperatively	No