Elder Surgery - Functional Recovery Following Beta Blockade

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Cognitive Dysfunction
• Intervention / Treatment: Drug: Atenolol

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.

• Study Type: Interventional
• Enrollment (Actual): 359
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • The Mayo Clinic
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atenolol; Atenolol given prior to and for up to 7 days after surgery	Drug: Atenolol; 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 Names: Tenormin
No Intervention: routine care; routine clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jefrey H. Silverstein, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: July 25, 2007
• First Submitted That Met QC Criteria: July 25, 2007
• First Posted (Estimate): July 26, 2007

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: functional recovery; beta blocker
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Atenolol
• Other Study ID Numbers: GCO 00-0100; AG018772 (Other Grant/Funding Number: National Institute on Aging (NIA))