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Completed

NCT Number: NCT01332812

Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

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.

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Key information

Conditions

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

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital of the University of São Paulo Medical School

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

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

Other names: The Dexamethasone and Index Bispectral

Control Group

Other

General anesthesia, without additional interventions

Other names: Index Bispectral and not received the Desamethasone

Primary outcomes

  1. Score in neuropsycological tests.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Duke University
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2011
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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