Full Text View
Tabular View
No Study Results Posted
Related Studies
Elder Surgery - Functional Recovery Following Beta Blockade
This study is ongoing, but not recruiting participants.
First Received: July 25, 2007   Last Updated: May 23, 2008   History of Changes
Sponsors and Collaborators: Mount Sinai School of Medicine
National Institute on Aging (NIA)
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00507663
  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: Tenormin
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:


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

Estimated Enrollment: 600
Study Start Date: September 2002
Estimated Study Completion Date: August 2008
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507663

Locations
United States, Minnesota
The Mayo Clinic
Rochester, Minnesota, United States
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
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

Study ID Numbers: 00-0100, AG018772
Study First Received: July 25, 2007
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00507663     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Atenolol
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cognition Disorders

ClinicalTrials.gov processed this record on July 06, 2009