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Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General Anesthesia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01332812
Enrollment
300
Registered
2011-04-11
Start date
2011-01-31
Completion date
2013-03-31
Last updated
2015-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Keywords

Dexamethasone, Postoperative cognitive dysfunction, General Anesthesia, neuropsychological tests

Brief summary

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.

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.

Interventions

DRUGDexamethasone

a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia

OTHERcontrol group

General anesthesia, without additional interventions

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Duke University
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Score in neuropsycological tests.6 months.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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026