Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332812
• Other study ID #: Maria J.C. Carmona
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2011
• Last updated: September 4, 2015
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Cognitive Dysfunction

Intervention

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

Locations

Country	Name	City	State
Brazil	General Hospital of the University of São Paulo Medical School	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Duke University, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score in neuropsycological tests.	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.	6 months.	Yes