Elder Surgery - Functional Recovery Following Beta Blockade
Completed · Phase 4
Conditions studied: Post Operative Cognitive Dysfunction
In brief
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.
Key facts
- Study ID
- NCT00507663
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 359
- Starts
- 2002-09-01
- Expected to finish
- 2007-11-01
- Last updated by the study team
- 2016-03-16
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- The Mayo Clinic — Rochester, Minnesota, United States
- NYU School of Medicine — New York, New York, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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