search
Back to results

Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

Primary Purpose

Postoperative Delirium

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Bispectral index, as measured by a BIS processor
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium focused on measuring Postoperative delirium

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Anesthesiology, Faculty of Medicine, Chiang Mai UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bispectral index (BIS) group

Control group

Arm Description

Bispectral index as measured by a BIS Processor is used to guide doses of anesthetic for maintaining the BIS values of 40-60

Clinical signs is used to guide doses of anestheitics.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients with impaired cognitive function
Assessed postoperative cognitive function by using Mini-Mental State Examination and Montreal Cognitive Assessment (MoCA) .
Time to recovery
Time between end of anesthesia and eye opening, spontaneous breathing, and extubation.

Full Information

First Posted
May 2, 2014
Last Updated
May 8, 2014
Sponsor
Chiang Mai University
Collaborators
National Research Council of Thailand
search

1. Study Identification

Unique Protocol Identification Number
NCT02133430
Brief Title
Optimized Anesthesia to Reduce Incidence of Postoperative Delirium
Official Title
Optimized Anesthesia to Reduce Incidence of Postoperative Delirium in Elderly Undergoing Elective, Non-cardiac Surgery: a Randomized Controlled Trial (POD-II)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University
Collaborators
National Research Council of Thailand

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
Postoperative delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bispectral index (BIS) group
Arm Type
Experimental
Arm Description
Bispectral index as measured by a BIS Processor is used to guide doses of anesthetic for maintaining the BIS values of 40-60
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Clinical signs is used to guide doses of anestheitics.
Intervention Type
Device
Intervention Name(s)
Bispectral index, as measured by a BIS processor
Other Intervention Name(s)
BIS PROCESSOR, MODEL QE-910P, NIHON KOHDEN CORPORATION
Intervention Description
Comparisons of incidence of postoperative delirium.
Primary Outcome Measure Information:
Title
Number of patients have postoperative delirium
Description
Assess postoperative delirium by using Confusion Assessment Method for intensive care unit (CAM-ICU) at recovery room and Confusion Assessment Method at inpatient ward.
Time Frame
Participants will be followed during the duration of hospital stay, an expected avarage of two weeks.
Secondary Outcome Measure Information:
Title
Number of patients with impaired cognitive function
Description
Assessed postoperative cognitive function by using Mini-Mental State Examination and Montreal Cognitive Assessment (MoCA) .
Time Frame
Up to 6 months
Title
Time to recovery
Description
Time between end of anesthesia and eye opening, spontaneous breathing, and extubation.
Time Frame
The end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Yodying Punjasawadwong, MD
Phone
+66819928082
Email
typunja@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Tanyong Pipanmekaporn, MD
Phone
+66817648677
Email
tanyong24@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Yodying Punjasawadwong, MD
Organizational Affiliation
Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, Thailand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Tanyong Pipanmekaporn, MD
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand,50200
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
City
Maung
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Yodying Punjasawadwong
Phone
+66819928082
Email
typunja@gmail.com

12. IPD Sharing Statement

Links:
URL
http://www.med.cmu.ac.th
Description
Sponsor's website

Learn more about this trial

Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

We'll reach out to this number within 24 hrs