DeliriumADAPT2NCT01983384
Anesthetic Depth and Postoperative Delirium Trial - 2
A study testing Processed EEG-guided anesthetic depth in people with Delirium and Cognitive Disorders, run by University of California, San Francisco at 1 site in United States.
Trial summary
Recent limited evidence suggests that anesthetic depth may influence postoperative cognitive outcomes, however, the mechanism between this association is unclear. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Cognitive Disorders
- What is being tested?
- Processed EEG-guided anesthetic depth
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2017
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years and older of age undergoing non-cardiac surgery, requiring hospital stay of 2 or more days.
Who cannot join
- patients who are not fluent in English or cannot provide informed consent
- patients who may not tolerate either light or deep anesthesia (history of heart failure, coronary artery disease, substance abuse)
- history of intraoperative recall or awareness during anesthesia
- pathologies of the brain which may affect EEG monitoring
- patients who are anticipated to have consecutive surgery within 3 days of first procedure
- patients who have had surgery with general anesthesia in the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco Medical Center
San Francisco, California, 94143-0648
About this study
Official title: A Randomised Controlled Trial to Reduce Postoperative Delirium Through Reduction in Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery
Recent limited evidence suggests that anesthetic depth may influence postoperative cognitive outcomes, however, the mechanism between this association is unclear.
Read the detailed description
Recently, it has been proposed that use of a processed electroencephalogram (EEG) monitor during surgery may be associated with a lower rate of postoperative delirium. In fact, some suggest that older patients undergoing surgery should routinely be monitored with an anesthetic depth monitor to allow the titration of anesthetics or sedation medications to lighter levels to promote better postoperative cognitive outcomes. Recent studies, including preliminary results from our group, have demonstrated electroencephalogram (EEG) suppression to be an independent risk factor for postoperative delirium.
Prior studies that have focused on risk prediction have shown age and prior cognitive impairment to be the most consistent risk factors for postoperative delirium. However, as of yet, no clinical trial has identified a relationship whether use of processed EEG monitor resulted in a reduction of incident postoperative delirium through a reduction in EEG suppression, with proper consideration of patients' baseline cognitive status as a potential moderator. Additionally, use of anesthetic depth monitor to keep patients' anesthetic depth above a specified value has never been validated or proven to be feasible or safe.
Accordingly, the investigators plan an exploratory study to: 1) determine whether the use of processed EEG to keep anesthetic depth above a specified level, results in a reduction in EEG suppression when compared to standard anesthetic care, 2) to determine whether preoperative level of cognitive function moderates the effect of group assignment on EEG suppression, and 3) to determine the feasibility and safety of using processed EEG-guided to keep patients' anesthetic depth above a specified value. A secondary aim was to determine the effect size for the intervention to reduce postoperative delirium for subjects with and without preoperative cognitive impairment for a future trial.
- Conditions
- Delirium, Cognitive Disorders
- Being tested
- Processed EEG-guided anesthetic depth
- Keywords
- Delirium, Cognition, Surgery, Anesthesia, Aging, Electroencephalography
- Medical subject headings
- Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed EEG-guided anesthetic depthOther
Investigators will undertake a randomized control trial in a cohort of older patients undergoing major non-cardiac surgery to receive either a control vs. an intervention of anesthesia as determined by a processed electroencephalogram
| Study group | Role | What they receive |
|---|---|---|
| Anesthetic Depth: standard care | Placebo comparator | A cohort of older patients undergoing major non-cardiac surgery will be randomized to receive routine anesthetic management not guided by the processed electroencephalogram Receives: Other: Processed EEG-guided anesthetic depth |
| Anesthetic Depth: interventional | Experimental | A cohort of older patients undergoing major non-cardiac surgery will be randomized to receive anesthetic management guided by the processed electroencephalogram (processed EEG-guided anesthetic depth) Receives: Other: Processed EEG-guided anesthetic depth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative EEG Suppression
Intraoperative EEG suppression will be measured by processed EEG monitor
Measured: Patients will be monitored by processed EEG intraoperatively, for the duration of surgery
Secondary outcomes (7)
Preoperative level of cognitive function
Level of cognitive function will be measured by Telephone Interview for Cognitive Status
Measured: Up to one week before surgery
Patient intraoperative awareness and recall
Intraoperative recall and awareness measured using modified Brice questionnaire (2 question survey - each answered with a yes or no, with additional checkboxes for applicable descriptions of events recalled [e.g. "Hearing voices," "Feeling pain," etc]) Patients answering yes to either question are classified as accidental awareness after general anesthesia (AAGA), which is regarded as an intraoperative adverse event.
Measured: Intraoperative recall and awareness will be measured within 72 hours after end of surgery
Patient movement
Patient movement will be recorded from the anesthesia record
Measured: During surgery
Intraoperative systolic and diastolic blood pressure
Intraoperative systolic and diastolic blood pressure will be continuously downloaded onto a computer for subsequent analysis. Increases or decreases above the preoperative baseline measurements will be measured and recorded from the medical record
Measured: During surgery
Intraoperative heart rate
Intraoperative heart rate will be continuously downloaded onto a computer for subsequent analysis. Increases or decreases above the preoperative baseline measurements will be measured and recorded from the medical record
Measured: During surgery
Anesthesiologists' adherence to assigned processed EEG index in the interventional group
Anesthesiologists' assigned to patients randomized to the interventional group were given a short self-report survey at the end of each surgery (e.g. "Did the PSI go below the PSI threshold of 35 at any point during surgery?")
Measured: Anesthesiologists complete self-report within 72 hours after end of surgery. This outcome measure is collected once for each patient through study completion, an average of 2 years.
Postoperative delirium
Research staff, blinded to group assignment, will assess for delirium using the Confusion Assessment Method, a physician-validated screening tool for hospital delirium
Measured: Daily for three postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJul 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Patients will be assigned to receive processed EEG-guided anesthesia or standard anesthetic care. Patients in both groups will be monitored with processed EEG, however those in the standard care group will have the anesthesiologist blinded to the machine. Patients in the interventional group receive processed EEG-guided anesthetic maintenance.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Sponsor
- Investigators
- Jacqueline Leung, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983384
- Sponsor's protocol ID
- ANESDEPTH
- Acronym
- ADAPT2
- Status last verified
- Dec 2019
- First submitted
- 29 Oct 2013
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang CJ, Jin Z, Sands LP, Pleasants D, Tabatabai S, Hong Y, Leung JM. ADAPT-2: A Randomized Clinical Trial to Reduce Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery. Anesth Analg. 2020 Oct;131(4):1228-1236. doi: 10.1213/ANE.0000000000004713.
PubMed 32925344
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Reduce Postoperative Delirium Through Reduction in Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT01983384
- Acronym / sponsor ID
- ADAPT2 / ANESDEPTH
- Conditions
- Delirium, Cognitive Disorders
- Keywords
- Delirium, Cognition, Surgery, Anesthesia, Aging, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- Jul 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 14 Nov 2013 (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.
Recent limited evidence suggests that anesthetic depth may influence postoperative cognitive outcomes, however, the mechanism between this association is unclear.
Detailed description
Recently, it has been proposed that use of a processed electroencephalogram (EEG) monitor during surgery may be associated with a lower rate of postoperative delirium. In fact, some suggest that older patients undergoing surgery should routinely be monitored with an anesthetic depth monitor to allow the titration of anesthetics or sedation medications to lighter levels to promote better postoperative cognitive outcomes. Recent studies, including preliminary results from our group, have demonstrated electroencephalogram (EEG) suppression to be an independent risk factor for postoperative delirium.
Prior studies that have focused on risk prediction have shown age and prior cognitive impairment to be the most consistent risk factors for postoperative delirium. However, as of yet, no clinical trial has identified a relationship whether use of processed EEG monitor resulted in a reduction of incident postoperative delirium through a reduction in EEG suppression, with proper consideration of patients' baseline cognitive status as a potential moderator. Additionally, use of anesthetic depth monitor to keep patients' anesthetic depth above a specified value has never been validated or proven to be feasible or safe.
Accordingly, the investigators plan an exploratory study to: 1) determine whether the use of processed EEG to keep anesthetic depth above a specified level, results in a reduction in EEG suppression when compared to standard anesthetic care, 2) to determine whether preoperative level of cognitive function moderates the effect of group assignment on EEG suppression, and 3) to determine the feasibility and safety of using processed EEG-guided to keep patients' anesthetic depth above a specified value. A secondary aim was to determine the effect size for the intervention to reduce postoperative delirium for subjects with and without preoperative cognitive impairment for a future trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned to receive processed EEG-guided anesthesia or standard anesthetic care. Patients in both groups will be monitored with processed EEG, however those in the standard care group will have the anesthesiologist blinded to the machine. Patients in the interventional group receive processed EEG-guided anesthetic maintenance.
| Arm | Type | Receives |
|---|---|---|
| Anesthetic Depth: standard care | Placebo comparator | Other: Processed EEG-guided anesthetic depthA cohort of older patients undergoing major non-cardiac surgery will be randomized to receive routine anesthetic management not guided by the processed electroencephalogram |
| Anesthetic Depth: interventional | Experimental | Other: Processed EEG-guided anesthetic depthA cohort of older patients undergoing major non-cardiac surgery will be randomized to receive anesthetic management guided by the processed electroencephalogram (processed EEG-guided anesthetic depth) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years and older of age undergoing non-cardiac surgery, requiring hospital stay of 2 or more days.
Key exclusion criteria (6 listed)
- patients who are not fluent in English or cannot provide informed consent
- patients who may not tolerate either light or deep anesthesia (history of heart failure, coronary artery disease, substance abuse)
- history of intraoperative recall or awareness during anesthesia
- pathologies of the brain which may affect EEG monitoring
- patients who are anticipated to have consecutive surgery within 3 days of first procedure
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 |
|---|---|---|
| Processed EEG-guided anesthetic depthInvestigators will undertake a randomized control trial in a cohort of older patients undergoing major non-cardiac surgery to receive either a control vs. an intervention of anesthesia as determined by a processed electroencephalogram | Other | Anesthetic Depth: interventional, Anesthetic Depth: standard care |
Primary outcome
Intraoperative EEG Suppression
Time frame: Patients will be monitored by processed EEG intraoperatively, for the duration of surgery
Intraoperative EEG suppression will be measured by processed EEG monitor
7 secondary outcomes
Preoperative level of cognitive function
Time frame: Up to one week before surgery
Patient intraoperative awareness and recall
Time frame: Intraoperative recall and awareness will be measured within 72 hours after end of surgery
Patient movement
Time frame: During surgery
Intraoperative systolic and diastolic blood pressure
Time frame: During surgery
Intraoperative heart rate
Time frame: During surgery
Anesthesiologists' adherence to assigned processed EEG index in the interventional group
Time frame: Anesthesiologists complete self-report within 72 hours after end of surgery. This outcome measure is collected once for each patient through study completion, an average of 2 years.
Postoperative delirium
Time frame: Daily for three postoperative days.
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 18 Dec 2019.
- Derived from this study: PubMed 32925344Tang CJ, Jin Z, Sands LP, Pleasants D, Tabatabai S, Hong Y, Leung JM. ADAPT-2: A Randomized Clinical Trial to Reduce Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery. Anesth Analg. 2020 Oct;131(4):1228-1236. doi: 10.1213/ANE.0000000000004713.
- 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.
Jacqueline Leung, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processed EEG-guided anesthetic depth in people with Delirium and Cognitive Disorders, run by University of California, San Francisco at 1 site in United States.
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 1 inclusion and 6 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 18 Dec 2019. 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 United States. 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?
Intraoperative EEG Suppression (time frame: Patients will be monitored by processed EEG intraoperatively, for the duration of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01983384, which also lists 1 linked publication.
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 18 Dec 2019.