Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

May 8, 2014 updated by: Dr. Yodying Punjasawadwong, Chiang Mai University

Optimized Anesthesia to Reduce Incidence of Postoperative Delirium in Elderly Undergoing Elective, Non-cardiac Surgery: a Randomized Controlled Trial (POD-II)

The purpose of this study is to compare the difference of incidence of postoperative delirium between patients received general anesthesia guided by Bispectral index (BIS) and patients received general anesthesia using standard technique.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

General anesthesia is one of precipitating factor of postoperative delirium which Its mechanism is still unknown. General anesthesia can affect on pattern of electroencephalograph. Previous studies showed that patients received BIS guided anesthesia could wake up faster, earlier extubation and stay in recovery room shorter compared to standard general anesthesia. Optimized level of anesthesia by BIS could reduce cognitive dysfunction in elderly patients and reduce biological marker of brain injury. Therefore, the investigators hypothesized that adjustment of general anesthesia by BIS guided could protect central nervous system and reduce incidence of postoperative delirium.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chiang Mai
      • Maung, Chiang Mai, Thailand, 50200
        • Recruiting
        • Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 95 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients age equal or more than 65 years.
  • Patients undergoing general anesthesia.
  • Patients undergoing scheduled, non-cardiac surgery

Exclusion Criteria:

  • Patients undergoing neurosurgery.
  • Patients cannot understand Thai language.
  • Patients who have severe visual or hearing impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bispectral index (BIS) group
Bispectral index as measured by a BIS Processor is used to guide doses of anesthetic for maintaining the BIS values of 40-60
Device: Bispectral index, as measured by a BIS processor
Comparisons of incidence of postoperative delirium.
Other Names:
  • BIS PROCESSOR, MODEL QE-910P, NIHON KOHDEN CORPORATION
NO_INTERVENTION: Control group
Clinical signs is used to guide doses of anestheitics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients have postoperative delirium
Time Frame: Participants will be followed during the duration of hospital stay, an expected avarage of two weeks.
Assess postoperative delirium by using Confusion Assessment Method for intensive care unit (CAM-ICU) at recovery room and Confusion Assessment Method at inpatient ward.
Participants will be followed during the duration of hospital stay, an expected avarage of two weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with impaired cognitive function
Time Frame: Up to 6 months
Assessed postoperative cognitive function by using Mini-Mental State Examination and Montreal Cognitive Assessment (MoCA) .
Up to 6 months
Time to recovery
Time Frame: The end of surgery
Time between end of anesthesia and eye opening, spontaneous breathing, and extubation.
The end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Collaborators

National Research Council of Thailand

Investigators

  • Principal Investigator: Dr. Yodying Punjasawadwong, MD, Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, Thailand
  • Study Director: Dr. Tanyong Pipanmekaporn, MD, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand,50200

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

April 1, 2015

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (ESTIMATE)

May 8, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANE-2556-01778

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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