Elder Surgery - Functional Recovery Following Beta Blockade

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeff Silverstein. MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00507663
First received: July 25, 2007
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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.

Condition Intervention Phase
Post Operative Cognitive Dysfunction
Drug: Atenolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Elder Surgery - Functional Recovery Following Beta Blockade

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Long Term Functional Recovery [ Time Frame: at 3 weeks after surgery ] [ Designated as safety issue: No ]
    self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).


Secondary Outcome Measures:
  • Timed Up and Go test [ Time Frame: preoperatively ] [ Designated as safety issue: No ]
    assesses basic functional mobility

  • Timed Up and Go test [ Time Frame: once at 7-10 days postoperatively ] [ Designated as safety issue: No ]
    assesses basic functional mobility

  • Timed Up and Go test [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]
    assesses basic functional mobility

  • Timed Up and Go test [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    assesses basic functional mobility

  • Timed Up and Go test [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
    assesses basic functional mobility

  • Hand grip strength [ Time Frame: preoperatively ] [ Designated as safety issue: No ]
    performance-based measure of upper extremity strength.

  • Hand grip strength [ Time Frame: once at 7-10 days postoperatively ] [ Designated as safety issue: No ]
    performance-based measure of upper extremity strength.

  • Hand grip strength [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]
    performance-based measure of upper extremity strength.

  • Hand grip strength [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    performance-based measure of upper extremity strength.

  • Hand grip strength [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
    performance-based measure of upper extremity strength.


Enrollment: 359
Study Start Date: September 2002
Study Completion Date: August 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Tenormin
No Intervention: routine care
routine clinical care

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unable to give informed consent to participate
  2. Folstein Mini-Mental State Examination Score < 17
  3. Gastrostomy tube placement
  4. Laparoscopic cholecystectomy, laparoscopic Nissen fundoplication, or any type of Hernia repair
  5. Appendectomy
  6. Emergency surgery
  7. Contraindications to adrenergic antagonists (third-degree heart block, decompensated congestive heart failure, active bronchospasm)
  8. Surgery within the previous month
  9. Major systemic infections
  10. Allergies to or incompatibilities with any drug used in this study
  11. Principle language other than English or Spanish
  12. Residence greater than 100 miles away from Manhattan
  13. 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)
  14. Chronic opioid usage
  15. Immunosuppression (subsequent opportunistic infections may obscure postoperative recovery).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507663

Locations
United States, Minnesota
The Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Jefrey H. Silverstein, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Jeff Silverstein. MD, MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00507663     History of Changes
Other Study ID Numbers: 00-0100, AG018772
Study First Received: July 25, 2007
Last Updated: January 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
beta blocker
functional recovery

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Atenolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014