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

April 7, 2011
January 3, 2013
January 2011
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01332812 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction
Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General 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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Postoperative Cognitive Dysfunction
  • Drug: Dexamethasone
    a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia
  • Other: control group
    General anesthesia, without additional 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.

    Intervention: Drug: Dexamethasone
  • 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.

    Intervention: Other: control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
March 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
60 Years to 90 Years
No
Contact: Maria J.C. Carmona, M.D. 55-11-3069-6335 maria.carmona@incor.usp.br
Brazil
 
NCT01332812
Maria J.C. Carmona
Yes
Maria José Carvalho Carmona, University of Sao Paulo
University of Sao Paulo
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Duke University
Not Provided
University of Sao Paulo
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP