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Elder Surgery - Functional Recovery Following Beta Blockade

14. März 2016 aktualisiert von: Icahn School of Medicine at Mount Sinai

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.

Studienübersicht

Status

Abgeschlossen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

359

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Minnesota
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • The Mayo Clinic
    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • Icahn School Of Medicine At Mount Sinai
      • New York, New York, Vereinigte Staaten, 10016
        • NYU School of Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

65 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Andere Namen:
  • Tenormin
Kein Eingriff: routine care
routine clinical care

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Long Term Functional Recovery
Zeitfenster: at 3 weeks after surgery
self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).
at 3 weeks after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Timed Up and Go test
Zeitfenster: preoperatively
assesses basic functional mobility
preoperatively
Timed Up and Go test
Zeitfenster: once at 7-10 days postoperatively
assesses basic functional mobility
once at 7-10 days postoperatively
Timed Up and Go test
Zeitfenster: 1 month postoperatively
assesses basic functional mobility
1 month postoperatively
Timed Up and Go test
Zeitfenster: 3 months postoperatively
assesses basic functional mobility
3 months postoperatively
Timed Up and Go test
Zeitfenster: 6 months postoperatively
assesses basic functional mobility
6 months postoperatively
Hand grip strength
Zeitfenster: preoperatively
performance-based measure of upper extremity strength.
preoperatively
Hand grip strength
Zeitfenster: once at 7-10 days postoperatively
performance-based measure of upper extremity strength.
once at 7-10 days postoperatively
Hand grip strength
Zeitfenster: 1 month postoperatively
performance-based measure of upper extremity strength.
1 month postoperatively
Hand grip strength
Zeitfenster: 3 months postoperatively
performance-based measure of upper extremity strength.
3 months postoperatively
Hand grip strength
Zeitfenster: 6 months postoperatively
performance-based measure of upper extremity strength.
6 months postoperatively

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Jefrey H. Silverstein, MD, Icahn School Of Medicine At Mount Sinai

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2002

Primärer Abschluss (Tatsächlich)

1. November 2007

Studienabschluss (Tatsächlich)

1. November 2007

Studienanmeldedaten

Zuerst eingereicht

25. Juli 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juli 2007

Zuerst gepostet (Schätzen)

26. Juli 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

16. März 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. März 2016

Zuletzt verifiziert

1. März 2016

Mehr Informationen

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