Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Postoperative Cognitive Dysfunction

Treatments: Other: control group; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01332812

Maria J.C. Carmona

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

Dexamethasone, POCD, psycological tests

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Control, POCD, psycological tests

Sham Comparator group

Description:

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.

Treatment:

Other: control group