Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

Phase 4

Completed

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Drug: Dexamethasone; Other: control group

• Registration Number: NCT01332812
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-04
• Disposition First Submitted QC: 2015-09-04
• Last Update Submitted: 2015-09-04
• Disposition First Posted: 2015-09-10
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone, POCD, psycological tests	Dexamethasone	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.
Control, POCD, psycological tests	control group	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

General Hospital of the University of São Paulo Medical School; 🇧🇷 São Paulo, Brazil