Postoperative DeliriumPhase 2/3NCT02133430
Optimized Anesthesia to Reduce Incidence of Postoperative Delirium
A Phase 2/3 study testing Bispectral index, as measured by a BIS processor in people with Postoperative Delirium, run by Chiang Mai University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Bispectral index, as measured by a BIS processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2014to Apr 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients age equal or more than 65 years.
- Patients undergoing general anesthesia.
- Patients undergoing scheduled, non-cardiac surgery
Who cannot join
- Patients undergoing neurosurgery.
- Patients cannot understand Thai language.
- Patients who have severe visual or hearing impairment.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
Maung, Chiang Mai, 50200
Dr. Yodying Punjasawadwong, +66819928082, typunja@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Delirium
- Being tested
- Bispectral index, as measured by a BIS processor
- Keywords
- Postoperative delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index, as measured by a BIS processorDevice
Also called BIS PROCESSOR, MODEL QE-910P, NIHON KOHDEN CORPORATION
Comparisons of incidence of postoperative delirium.
| Study group | Role | What they receive |
|---|---|---|
| Bispectral index (BIS) group | Experimental | Bispectral index as measured by a BIS Processor is used to guide doses of anesthetic for maintaining the BIS values of 40-60 Receives: Device: Bispectral index, as measured by a BIS processor |
| Control group | No intervention | Clinical signs is used to guide doses of anestheitics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Assessed postoperative cognitive function by using Mini-Mental State Examination and Montreal Cognitive Assessment (MoCA) .
Measured: Up to 6 months
Time to recovery
Time between end of anesthesia and eye opening, spontaneous breathing, and extubation.
Measured: The end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Principal investigator, Dr. Yodying Punjasawadwong, Chiang Mai University
- Investigators
- Dr. Yodying Punjasawadwong, MD, Principal investigator, Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, ThailandDr. Tanyong Pipanmekaporn, MD, Study director, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand,50200
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133430
- Sponsor's protocol ID
- ANE-2556-01778
- Status last verified
- May 2014
- First submitted
- 2 May 2014
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Anesthesia to Reduce Incidence of Postoperative Delirium in Elderly Undergoing Elective, Non-cardiac Surgery: a Randomized Controlled Trial (POD-II)
- ClinicalTrials.gov ID
- NCT02133430
- Acronym / sponsor ID
- ANE-2556-01778
- Conditions
- Postoperative Delirium
- Keywords
- Postoperative delirium
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bispectral index (BIS) group | Experimental | Device: Bispectral index, as measured by a BIS processorBispectral 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 intervention | –Clinical signs is used to guide doses of anestheitics. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients age equal or more than 65 years.
- Patients undergoing general anesthesia.
- Patients undergoing scheduled, non-cardiac surgery
Key exclusion criteria (3 listed)
- Patients undergoing neurosurgery.
- Patients cannot understand Thai language.
- Patients who have severe visual or hearing impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral index, as measured by a BIS processorAlso: BIS PROCESSOR, MODEL QE-910P, NIHON KOHDEN CORPORATIONComparisons of incidence of postoperative delirium. | Device | Bispectral index (BIS) group |
Primary outcome
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.
2 secondary outcomes
Number of patients with impaired cognitive function
Time frame: Up to 6 months
Time to recovery
Time frame: The end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
- Sponsor's websiteLink provided by the sponsor.
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Yodying Punjasawadwong, MD principal investigator
Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, Thailand
Dr. Tanyong Pipanmekaporn, MD study director
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand,50200
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bispectral index, as measured by a BIS processor in people with Postoperative Delirium, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Yodying Punjasawadwong, MD (+66819928082, typunja@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients have postoperative delirium (time frame: Participants will be followed during the duration of hospital stay, an expected avarage of two weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.