Optimized Anesthesia to Reduce Incidence of Postoperative Delirium
1 other identifier
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 2, 2014
CompletedFirst Posted
Study publicly available on registry
May 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 12, 2014
May 1, 2014
1.1 years
May 2, 2014
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients have postoperative delirium
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 Outcomes (2)
Number of patients with impaired cognitive function
Up to 6 months
Time to recovery
The end of surgery
Study Arms (2)
Bispectral index (BIS) group
EXPERIMENTALBispectral index as measured by a BIS Processor is used to guide doses of anesthetic for maintaining the BIS values of 40-60
Control group
NO INTERVENTIONClinical signs is used to guide doses of anestheitics.
Interventions
Comparisons of incidence of postoperative delirium.
Eligibility Criteria
You may qualify if:
- Patients age equal or more than 65 years.
- Patients undergoing general anesthesia.
- Patients undergoing scheduled, non-cardiac surgery
You may not qualify if:
- Patients undergoing neurosurgery.
- Patients cannot understand Thai language.
- Patients who have severe visual or hearing impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chiang Mai Universitylead
- National Research Council of Thailandcollaborator
Study Sites (1)
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
Maung, Chiang Mai, 50200, Thailand
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 2, 2014
First Posted
May 8, 2014
Study Start
January 1, 2014
Primary Completion
February 1, 2015
Study Completion
April 1, 2015
Last Updated
May 12, 2014
Record last verified: 2014-05