Elder Surgery - Functional Recovery Following Beta Blockade
Primary Purpose
Post Operative Cognitive Dysfunction
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atenolol
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Cognitive Dysfunction focused on measuring beta blocker, functional recovery
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- The Mayo Clinic
- NYU School of Medicine
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Atenolol
routine care
Arm Description
Atenolol given prior to and for up to 7 days after surgery
routine clinical care
Outcomes
Primary Outcome Measures
Long Term Functional Recovery
self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).
Secondary Outcome Measures
Timed Up and Go test
assesses basic functional mobility
Timed Up and Go test
assesses basic functional mobility
Timed Up and Go test
assesses basic functional mobility
Timed Up and Go test
assesses basic functional mobility
Timed Up and Go test
assesses basic functional mobility
Hand grip strength
performance-based measure of upper extremity strength.
Hand grip strength
performance-based measure of upper extremity strength.
Hand grip strength
performance-based measure of upper extremity strength.
Hand grip strength
performance-based measure of upper extremity strength.
Hand grip strength
performance-based measure of upper extremity strength.
Full Information
NCT ID
NCT00507663
First Posted
July 25, 2007
Last Updated
March 14, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00507663
Brief Title
Elder Surgery - Functional Recovery Following Beta Blockade
Official Title
Elder Surgery - Functional Recovery Following Beta Blockade
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
to see if it improves or quickens your recovery from anesthesia and surgery.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Cognitive Dysfunction
Keywords
beta blocker, functional recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
359 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atenolol
Arm Type
Experimental
Arm Description
Atenolol given prior to and for up to 7 days after surgery
Arm Title
routine care
Arm Type
No Intervention
Arm Description
routine clinical care
Intervention Type
Drug
Intervention Name(s)
Atenolol
Other Intervention Name(s)
Tenormin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Long Term Functional Recovery
Description
self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).
Time Frame
at 3 weeks after surgery
Secondary Outcome Measure Information:
Title
Timed Up and Go test
Description
assesses basic functional mobility
Time Frame
preoperatively
Title
Timed Up and Go test
Description
assesses basic functional mobility
Time Frame
once at 7-10 days postoperatively
Title
Timed Up and Go test
Description
assesses basic functional mobility
Time Frame
1 month postoperatively
Title
Timed Up and Go test
Description
assesses basic functional mobility
Time Frame
3 months postoperatively
Title
Timed Up and Go test
Description
assesses basic functional mobility
Time Frame
6 months postoperatively
Title
Hand grip strength
Description
performance-based measure of upper extremity strength.
Time Frame
preoperatively
Title
Hand grip strength
Description
performance-based measure of upper extremity strength.
Time Frame
once at 7-10 days postoperatively
Title
Hand grip strength
Description
performance-based measure of upper extremity strength.
Time Frame
1 month postoperatively
Title
Hand grip strength
Description
performance-based measure of upper extremity strength.
Time Frame
3 months postoperatively
Title
Hand grip strength
Description
performance-based measure of upper extremity strength.
Time Frame
6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jefrey H. Silverstein, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Elder Surgery - Functional Recovery Following Beta Blockade
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