DeliriumNCT05656703
Anesthesia Depth Increases Delirium Incidence
A study testing BIS guidance of anesthesia in people with Delirium and Anesthesia Awareness, run by Heidelberg University at 1 site in Germany.
Trial summary
This study aimed to determine whether targeting bispectral index (BIS) readings of 55 (light anaesthesia) was associated with a lower incidence of delirium, dementia (POD), POCD and mortality but higher rates of awareness and complications than a standard of care anaesthesia blinded to depth monitoring. Read more about this study
- Who is it for?
- Ages 70 to 110 years
- Conditions the study is for
- Delirium, Anesthesia Awareness
- What is being tested?
- BIS guidance of anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2015to 15 Mar 2021
- Phase
- Interventional
- 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 70 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- scheduled for major surgery above 60 min duration
- informed consent
Who cannot join
- emergency surgery with large blood loss and/or preoperative cardiovascular instability, scheduled regional or neuraxial anesthesia, language barriers with the unability to understand a German audio tape, unability or unwillingness to consent,hearing disabilities
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: Monitoring of Anesthesia Depth Reduces the Incidence of Postoperative Delirium and Preserves Memory Abilities Better in the High Risk Elderly
This study aimed to determine whether targeting bispectral index (BIS) readings of 55 (light anaesthesia) was associated with a lower incidence of delirium, dementia (POD), POCD and mortality but higher rates of awareness and complications than a standard of care anaesthesia blinded to depth monitoring.
Read the detailed description
Design: Randomised-controlled, double blind study, monocentric Setting: Level 2 medical center, major surgery (non cardiac) Ethics: Ethical approval for this study (Ethikkommission II der Ruprecht-Karls-Universität Heidelberg 2013-627N-MA) was provided by the Ethical Committee II University Medicine Mannheim, University of Heidelberg, Germany (Chairperson Prof W. Striebel) on Mai 12th 2008.
Patients: n=130, aged > 70y Intervention: Light anesthesia (BIS 55 +/-5) vs. Standard of Care (BIS- blinded) Main outcome measures: Incidence of awareness, delirium, postoperative cognitive deficit (POCD), dementia (POD), memory (MAT with a computerized score for verbal working\&short term, figural working\&short term memories and well as attention level) Second aims: mortality, complications
- Conditions
- Delirium, Anesthesia Awareness
- Being tested
- BIS guidance of anesthesia, Standard of Care
- Keywords
- bispectral index monitoring, anesthesia depth
- Medical subject headings
- Delirium, Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS guidance of anesthesiaDevice
Anesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics
Standard of CareOther
Anesthesia is administered as usual
| Study group | Role | What they receive |
|---|---|---|
| Bis Guided light anesthesia | Experimental | Patients are monitored by bispectral index and held under light anesthesia (BIS level 45 to 60) Receives: Device: BIS guidance of anesthesia |
| Standard of Care | Placebo comparator | Patients receive standard of care anesthesia, BIS monitor was covered with a blind Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium by NUDESC
in the hospital with NUDESC Score
Measured: 6 to 24 months
postoperative dementia and cognitive deficit By MMSE and MAT Test
in the hospital by MMSE and MAT (automated computerized test), after discharge by a standardized questionnaire
Measured: 6 to 24 months
awareness, memory function
implicit and explicit memory for intraoperative wakefulness and memory functions in general as changing conditions due to anesthesia
Measured: 1 to 3 days postoperative
Secondary outcomes (1)
mortality and morbidity
death rate (in hospital and longterm mortality (death/month)) and complication rate (in hospital and longterm morbidity (complications/month))
Measured: 6 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Sep 2015
- Primary completion1 Jun 2018
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised-controlled, double blind study, monocentric
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Frietsch, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656703
- Sponsor's protocol ID
- 2013-627N-MA
- Status last verified
- Dec 2022
- First submitted
- 12 May 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Anesthesia Depth Reduces the Incidence of Postoperative Delirium and Preserves Memory Abilities Better in the High Risk Elderly
- ClinicalTrials.gov ID
- NCT05656703
- Acronym / sponsor ID
- 2013-627N-MA
- Conditions
- Delirium, Anesthesia Awareness
- Keywords
- bispectral index monitoring, anesthesia depth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 19 Dec 2022 (actual)
- 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.
This study aimed to determine whether targeting bispectral index (BIS) readings of 55 (light anaesthesia) was associated with a lower incidence of delirium, dementia (POD), POCD and mortality but higher rates of awareness and complications than a standard of care anaesthesia blinded to depth monitoring.
Detailed description
Design: Randomised-controlled, double blind study, monocentric Setting: Level 2 medical center, major surgery (non cardiac) Ethics: Ethical approval for this study (Ethikkommission II der Ruprecht-Karls-Universität Heidelberg 2013-627N-MA) was provided by the Ethical Committee II University Medicine Mannheim, University of Heidelberg, Germany (Chairperson Prof W. Striebel) on Mai 12th 2008.
Patients: n=130, aged > 70y Intervention: Light anesthesia (BIS 55 +/-5) vs. Standard of Care (BIS- blinded) Main outcome measures: Incidence of awareness, delirium, postoperative cognitive deficit (POCD), dementia (POD), memory (MAT with a computerized score for verbal working\&short term, figural working\&short term memories and well as attention level) Second aims: mortality, complications
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised-controlled, double blind study, monocentric
| Arm | Type | Receives |
|---|---|---|
| Bis Guided light anesthesia | Experimental | Device: BIS guidance of anesthesiaPatients are monitored by bispectral index and held under light anesthesia (BIS level 45 to 60) |
| Standard of Care | Placebo comparator | Other: Standard of CarePatients receive standard of care anesthesia, BIS monitor was covered with a blind |
Who may qualify
- Ages
- 70 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- scheduled for major surgery above 60 min duration
- informed consent
Key exclusion criteria (1 listed)
- emergency surgery with large blood loss and/or preoperative cardiovascular instability, scheduled regional or neuraxial anesthesia, language barriers with the unability to understand a German audio tape, unability or unwillingness to consent,hearing disabilities
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 |
|---|---|---|
| BIS guidance of anesthesiaAnesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics | Device | Bis Guided light anesthesia |
| Standard of CareAnesthesia is administered as usual | Other | Standard of Care |
Primary outcome
postoperative delirium by NUDESC
Time frame: 6 to 24 months
in the hospital with NUDESC Score
postoperative dementia and cognitive deficit By MMSE and MAT Test
Time frame: 6 to 24 months
in the hospital by MMSE and MAT (automated computerized test), after discharge by a standardized questionnaire
awareness, memory function
Time frame: 1 to 3 days postoperative
implicit and explicit memory for intraoperative wakefulness and memory functions in general as changing conditions due to anesthesia
1 secondary outcome
mortality and morbidity
Time frame: 6 to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS guidance of anesthesia in people with Delirium and Anesthesia Awareness, run by Heidelberg University at 1 site in Germany.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 19 Dec 2022. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative delirium by NUDESC (time frame: 6 to 24 months). The study lists 3 primary outcomes in all. 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 19 Dec 2022.