Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

NCT01332812 | Completed Phase 4 DMC

• 1 other identifier: Maria J.C. Carmona
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

Dexamethasone; Postoperative cognitive dysfunction; General Anesthesia; neuropsychological tests

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Dexamethasone, POCD, psycological tests

EXPERIMENTAL

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

Control, POCD, psycological tests

SHAM COMPARATOR

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

Interventions

Dexamethasone DRUG

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

Also known as: The Dexamethasone and Index Bispectral

Dexamethasone, POCD, psycological tests

control group OTHER

General anesthesia, without additional interventions

Also known as: Index Bispectral and not received the Desamethasone

Control, POCD, psycological tests

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Duke University: collaborator

Study Sites (1)

General Hospital of the University of São Paulo Medical School

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• Valentin LS, Pereira VF, Pietrobon RS, Schmidt AP, Oses JP, Portela LV, Souza DO, Vissoci JR, Luz VF, Trintoni LM, Nielsen KC, Carmona MJ. Effects of Single Low Dose of Dexamethasone before Noncardiac and Nonneurologic Surgery and General Anesthesia on Postoperative Cognitive Dysfunction-A Phase III Double Blind, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0152308. doi: 10.1371/journal.pone.0152308. eCollection 2016.

  PMID: 27152422 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Dexamethasone; Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maria José C Carmona, M.D.

  Faculty of Medicine of the University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

BR (1)