Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

NCT ID: NCT02133430

Last Updated: 2014-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Bispectral index, as measured by a BIS processor

Intervention Type DEVICE

Comparisons of incidence of postoperative delirium.

Control group

Clinical signs is used to guide doses of anestheitics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bispectral index, as measured by a BIS processor

Comparisons of incidence of postoperative delirium.

Intervention Type DEVICE

Other Intervention Names

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BIS PROCESSOR, MODEL QE-910P, NIHON KOHDEN CORPORATION

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Yodying Punjasawadwong

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Yodying Punjasawadwong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, Thailand

Dr. Tanyong Pipanmekaporn, MD

Role: STUDY_DIRECTOR

Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand,50200

Locations

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Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

Maung, Chiang Mai, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Dr. Yodying Punjasawadwong, MD

Role: CONTACT

+66819928082

Dr. Tanyong Pipanmekaporn, MD

Role: CONTACT

+66817648677

Facility Contacts

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Dr. Yodying Punjasawadwong

Role: primary

+66819928082

Related Links

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http://www.med.cmu.ac.th

Sponsor's website

Other Identifiers

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ANE-2556-01778

Identifier Type: -

Identifier Source: org_study_id

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