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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:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


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
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