Elder Surgery - Functional Recovery Following Beta Blockade
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
-
Minnesota
-
Rochester, Minnesota, Spojené státy, 55905
- The Mayo Clinic
-
-
New York
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New York, New York, Spojené státy, 10029
- Icahn School of Medicine at Mount Sinai
-
New York, New York, Spojené státy, 10016
- NYU School of Medicine
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Atenolol
Atenolol given prior to and for up to 7 days after surgery
|
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.
Ostatní jména:
|
|
Žádný zásah: routine care
routine clinical care
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Long Term Functional Recovery
Časové okno: at 3 weeks after surgery
|
self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).
|
at 3 weeks after surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Timed Up and Go test
Časové okno: preoperatively
|
assesses basic functional mobility
|
preoperatively
|
|
Timed Up and Go test
Časové okno: once at 7-10 days postoperatively
|
assesses basic functional mobility
|
once at 7-10 days postoperatively
|
|
Timed Up and Go test
Časové okno: 1 month postoperatively
|
assesses basic functional mobility
|
1 month postoperatively
|
|
Timed Up and Go test
Časové okno: 3 months postoperatively
|
assesses basic functional mobility
|
3 months postoperatively
|
|
Timed Up and Go test
Časové okno: 6 months postoperatively
|
assesses basic functional mobility
|
6 months postoperatively
|
|
Hand grip strength
Časové okno: preoperatively
|
performance-based measure of upper extremity strength.
|
preoperatively
|
|
Hand grip strength
Časové okno: once at 7-10 days postoperatively
|
performance-based measure of upper extremity strength.
|
once at 7-10 days postoperatively
|
|
Hand grip strength
Časové okno: 1 month postoperatively
|
performance-based measure of upper extremity strength.
|
1 month postoperatively
|
|
Hand grip strength
Časové okno: 3 months postoperatively
|
performance-based measure of upper extremity strength.
|
3 months postoperatively
|
|
Hand grip strength
Časové okno: 6 months postoperatively
|
performance-based measure of upper extremity strength.
|
6 months postoperatively
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Jefrey H. Silverstein, MD, Icahn School of Medicine at Mount Sinai
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Patologické procesy
- Pooperační komplikace
- Neurokognitivní poruchy
- Poruchy kognice
- Kognitivní dysfunkce
- Pooperační kognitivní komplikace
- Fyziologické účinky léků
- Adrenergní beta-antagonisté
- Adrenergní antagonisté
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Látky proti arytmii
- Antihypertenziva
- Autonomní agenti
- Agenti periferního nervového systému
- Sympatolytika
- Antagonisté adrenergního beta-1 receptoru
- Atenolol
Další identifikační čísla studie
- GCO 00-0100
- AG018772 (Jiné číslo grantu/financování: National Institute on Aging (NIA))
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