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Elder Surgery - Functional Recovery Following Beta Blockade

14 mars 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

359

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Minnesota
      • Rochester, Minnesota, États-Unis, 55905
        • The Mayo Clinic
    • New York
      • New York, New York, États-Unis, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, États-Unis, 10016
        • NYU School of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Atenolol
Atenolol given prior to and for up to 7 days after surgery
Médicament: Atenolol
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.
Autres noms:
  • Tenormin
Aucune intervention: routine care
routine clinical care

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Long Term Functional Recovery
Délai: at 3 weeks after surgery
self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL).
at 3 weeks after surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Timed Up and Go test
Délai: preoperatively
assesses basic functional mobility
preoperatively
Timed Up and Go test
Délai: once at 7-10 days postoperatively
assesses basic functional mobility
once at 7-10 days postoperatively
Timed Up and Go test
Délai: 1 month postoperatively
assesses basic functional mobility
1 month postoperatively
Timed Up and Go test
Délai: 3 months postoperatively
assesses basic functional mobility
3 months postoperatively
Timed Up and Go test
Délai: 6 months postoperatively
assesses basic functional mobility
6 months postoperatively
Hand grip strength
Délai: preoperatively
performance-based measure of upper extremity strength.
preoperatively
Hand grip strength
Délai: once at 7-10 days postoperatively
performance-based measure of upper extremity strength.
once at 7-10 days postoperatively
Hand grip strength
Délai: 1 month postoperatively
performance-based measure of upper extremity strength.
1 month postoperatively
Hand grip strength
Délai: 3 months postoperatively
performance-based measure of upper extremity strength.
3 months postoperatively
Hand grip strength
Délai: 6 months postoperatively
performance-based measure of upper extremity strength.
6 months postoperatively

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Icahn School of Medicine at Mount Sinai

Collaborateurs

National Institute on Aging (NIA)

Les enquêteurs

  • Chercheur principal: Jefrey H. Silverstein, MD, Icahn School of Medicine at Mount Sinai

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2002

Achèvement primaire (Réel)

1 novembre 2007

Achèvement de l'étude (Réel)

1 novembre 2007

Dates d'inscription aux études

Première soumission

25 juillet 2007

Première soumission répondant aux critères de contrôle qualité

25 juillet 2007

Première publication (Estimation)

26 juillet 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

16 mars 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 mars 2016

Dernière vérification

1 mars 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GCO 00-0100
  • AG018772 (Autre subvention/numéro de financement: National Institute on Aging (NIA))

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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