Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Duke University
Information provided by (Responsible Party):
Maria José Carvalho Carmona, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01332812
First received: April 7, 2011
Last updated: January 3, 2013
Last verified: April 2011
  Purpose

This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.


Condition Intervention Phase
Postoperative Cognitive Dysfunction
Drug: Dexamethasone
Other: control group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General Anesthesia

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Score in neuropsycological tests. [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]
    Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery.


Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone, POCD, psycological tests

Subjects will be randomly assigned in two groups: For the Dexamethasone group, 8mg of dexamethasone will be administered intravenously before the induction of general anesthesia. For Control Group, no Dexamethasone will be administered.

Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery.

Drug: Dexamethasone
a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia
Sham Comparator: Control, POCD, psycological tests

Subjects will be randomly assigned in two groups: For the Dexamethasone group, 8mg of dexamethasone will be administered intravenously before the induction of general anesthesia. For Control Group, no Dexamethasone will be administered.

Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery.

Other: control group
General anesthesia, without additional interventions

Detailed Description:

Postoperative cognitive dysfunction is related with the use of opioids in the postoperative period, lack of physical activity, fatigue, postoperative pain and quality of life. The use of corticosteroids preoperatively reduces postoperative pain, fatigue, nausea and vomiting in the postoperative period and is frequently used as an adjuvant in anesthesia. This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients over 60 years,
  • underwent surgery for inguinal hernia repair, Nissen procedure, cholecystectomy or other surgeries midsize under general anesthesia and hospital stay expected within 72 hours.

Exclusion Criteria:

  • age less than 60 years,
  • history of brain disease or dementia, other psychiatric disorders that affect cognition,
  • lack of proficiency in Portuguese,
  • use of corticosteroids or opioid preoperatively.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332812

Contacts
Contact: Maria J.C. Carmona, M.D. 55-11-3069-6335 maria.carmona@incor.usp.br

Locations
Brazil
General Hospital of the University of São Paulo Medical School Recruiting
São Paulo, Brazil, 05403-000
Contact: Maria JC Carmona, Carmona    55-11-3069-6335    maria.carmona@incor.usp.br   
Contact: Lívia SS Valentin, Psy       lssv@usp.com.br   
Sub-Investigator: Lívia SS Valentin, Psy         
Principal Investigator: Maria JC Carmona, MD         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Duke University
  More Information

No publications provided

Responsible Party: Maria José Carvalho Carmona, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01332812     History of Changes
Other Study ID Numbers: Maria J.C. Carmona
Study First Received: April 7, 2011
Last Updated: January 3, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Dexamethasone
Postoperative cognitive dysfunction
General Anesthesia
neuropsychological tests

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anesthetics
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014