NCT00507663

Brief 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. 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. 2.to see if it improves or quickens your recovery from anesthesia and surgery.
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

5.2 years

First QC Date

July 25, 2007

Last Update Submit

March 14, 2016

Conditions

Post Operative Cognitive Dysfunction

Keywords

beta blockerfunctional recovery

Outcome Measures

Primary Outcomes (1)

  • Long Term Functional Recovery

    self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).

    at 3 weeks after surgery

Secondary Outcomes (10)

  • Timed Up and Go test

    preoperatively

  • Timed Up and Go test

    once at 7-10 days postoperatively

  • Timed Up and Go test

    1 month postoperatively

  • Timed Up and Go test

    3 months postoperatively

  • Timed Up and Go test

    6 months postoperatively

  • +5 more secondary outcomes

Study Arms (2)

Atenolol

EXPERIMENTAL

Atenolol given prior to and for up to 7 days after surgery

Drug: Atenolol

routine care

NO INTERVENTION

routine clinical care

Interventions

AtenololDRUG

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.

Also known as: Tenormin
Atenolol

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Atenolol

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Jefrey H. Silverstein, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 26, 2007

Study Start

September 1, 2002

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

US(3)