Elder Surgery - Functional Recovery Following Beta Blockade
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2002 |
| End Date: | November 2007 |
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.
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.
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.
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.
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).
We found this trial at
3
sites
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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