Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

This study has been completed.
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: September 4, 2015
Last verified: September 2015
  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.


Enrollment: 300
Study Start Date: January 2011
Study Completion Date: March 2013
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
Other Name: The Dexamethasone and Index Bispectral
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
Other Name: Index Bispectral and not received the Desamethasone

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   (Adult, Senior)
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

Locations
Brazil
General Hospital of the University of São Paulo Medical School
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Duke University
Investigators
Principal Investigator: Maria José C Carmona, M.D. Faculty of Medicine of the University of Sao Paulo
  More Information

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: September 4, 2015
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
Neurocognitive Disorders
Mental Disorders
Anesthetics
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2016