Neurocognitive DisordersPhase 4TIVA GASNCT06036095
Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study
A Phase 4 study testing Sevoflurane and Propofol in people with Neurocognitive Disorders and Anesthesia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Traditionally, general anesthesia is maintained with inhalational anesthesia (GAS), but there is a gap in knowledge regarding whether intravenous anesthesia (IV) can prevent deleterious postoperative outcomes in the geriatric surgical population. Read more about this study
- Who is it for?
- Ages 70 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Disorders, Anesthesia, Post-operative Delirium
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 15 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women ≥ 70 years
- Sufficient vision and hearing to complete all tests
- Proficient in spoken and written English
- Scheduled for elective, inpatient, noncardiac surgery, expected to last at least 120 minutes requiring general anesthesia
Who cannot join
- Urgent or emergent surgery
- Diagnosed dementia (or MoCA<19)
- History of Parkinson's disease, major psychiatric disease (Schizophrenia), or severe traumatic brain injury
- Ongoing alcohol or substance abuse (per DSM V criteria)
- Allergy to propofol or sevoflurane
- Personal or family history of malignant hyperthermia
Show all 11Show fewer
- Planned postoperative intubation
- Brain surgery
- Surgery requiring TIVA or GAS (i.e. cases involving neuromonitoring)
- Surgical procedure requiring general anesthetic occurring within 3 months (before or after) surgical date
- Any patient or perioperative factor considered a contraindication to randomization to either experimental group by the surgeon or anesthesiologist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Sarah Feller, BS, fellersa@ohsu.edu
Kimberly Chun, BS, chunk@ohsu.edu
About this study
Official title: Optimizing Anesthesia to Prevent Postoperative Cognitive and Functional Decline in Older Adults: A Randomized Controlled Trial
Traditionally, general anesthesia is maintained with inhalational anesthesia (GAS), but there is a gap in knowledge regarding whether intravenous anesthesia (IV) can prevent deleterious postoperative outcomes in the geriatric surgical population. The goal of this clinical trial is to determine whether intravenous anesthesia (IV) leads to a decreased incidence of postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and functional decline, and improved patient-reported outcomes (PROs) in older adults undergoing non-cardiac surgery when compared to the standard inhalational anesthesia (GAS). This single-center, 1:1 randomized, double-blind (patient \& outcome assessor) clinical trial will compare inhalational vs. intravenous anesthesia on POD, POCD, functional status, patient-reported outcomes (PROs), and blood-based biomarkers in older patients undergoing elective, inpatient, non-cardiac surgery. Upon enrollment, 260 women and men ≥ 70 years undergoing elective noncardiac surgery under general anesthesia will be randomized to 2 groups: TIVA or GAS.
Read the detailed description
Aim 1: Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium and postoperative cognitive dysfunction in older adults undergoing non-cardiac surgery.
Hypothesis: Intravenous anesthesia is associated with a lower incidence of POD and POCD compared to inhalational anesthesia.
Primary outcomes: Incidence of postoperative delirium and postoperative cognitive dysfunction Secondary outcomes: delirium severity, delirium duration Aim 2: Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline and patient-reported outcomes in older adults undergoing non-cardiac surgery.
Hypothesis: Intravenous anesthesia is associated with a lower incidence of postoperative functional decline and improved patient-reported outcomes (PROs) compared to inhalational anesthesia.
Primary outcomes: Incidence of postoperative functional decline; patient-reported outcome scores Aim 3: Determine the effects of intravenous vs. inhalational anesthesia on blood phosphorylated tau 181 (p-tau181) and other blood biomarkers in older adults undergoing non-cardiac surgery.
Hypothesis 1: Elevated preop blood p-tau181 is associated with increased POD and POCD; Hypothesis 2: Postoperative increase in blood p-tau181 is greater with GAS relative to IV; Hypothesis 3: Postop increases in blood biomarkers of neuroinflammation and AD pathology are greater with GAS relative to IV.
Primary outcomes: preoperative levels of blood p-tau181 and change in levels from preoperative baseline to postoperative.
Secondary outcomes: Other candidate biomarkers include those previously implicated in POD or POCD: p-tau217, Aβ,54 NF-L,55 High mobility group box protein 1 (HMGB1),60 S100β,76 interleukin (IL)-6,58 IL-1β,22 IL-10,46 tumor necrosis factor (TNF)-α,22 CCL2,62 and glial fibrillary acidic protein (GFAP).77
- Conditions
- Neurocognitive Disorders, Anesthesia, Post-operative Delirium, Post-operative Cognitive Dysfunction
- Being tested
- Sevoflurane, Propofol
- Medical subject headings
- Neurocognitive Disorders, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Inhalational Anesthesia
Inhalational maintenance of anesthesia group using sevoflurane
PropofolDrug
Also called Intravenous Anesthesia
Intravenous maintenance of anesthesia group using propofol
| Study group | Role | What they receive |
|---|---|---|
| Inhalational Anesthesia | Active comparator | Inhalational maintenance of anesthesia group using sevoflurane Receives: Drug: Sevoflurane |
| Intravenous Anesthesia | Active comparator | Intravenous maintenance of anesthesia group using propofol Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium in older surgical patients with the 3D-Confusion Assessment Method (3D-CAM-S) and the CAM-ICU-7.
Incidence of postoperative delirium with the 3D-Confusion Assessment Method (3D-CAM) in non-intubated patients and the CAM-ICU-7 in intubated patients. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3 while the patient is in the hospital.
Measured: through postoperative day 3
Determine the effects of intravenous vs. inhalational anesthesia on the incidence of postoperative neurocognitive disorder in older adults undergoing non-cardiac surgery using neuropsychiatric composite score.
Postoperative neurocognitive disorder. Change from preoperative baseline cognitive dysfunction using neuropsychiatric composite score. Battery of neuropsychological tests: Animal Verbal Fluency Test, Trail Making Test A \& B, Digit Symbol Test, Logical Memory Immediate \& Delayed Recall, and CERAD Word List Immediate and Delayed recall. MASQ will be used for subjective cognitive decline. Functional status will be measured by FAQ.
Measured: Change from preoperative baseline to one year.
Secondary outcomes (4)
Determine the effects of intravenous vs. inhalational anesthesia on incidence of delirium duration (days) and severity, measured by 3D-CAM-S, and CAM-ICU-7 in older adults undergoing non-cardiac surgery.
delirium severity and duration. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3.
Measured: through postoperative day 3
Effects of intravenous vs. inhalational anesthesia on levels of blood phosphorylated tau 181 (p-tau181) in older surgical patients.. Change from preoperative baseline blood p-tau181 to postoperative day 1, 3 months and 12 months.
change in levels of preoperative levels of blood p-tau181 from preoperative baseline to 12 months postoperative
Measured: Change from baseline through one year.
Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline using ADL, FAQ, and FRAIL in older adults undergoing non-cardiac surgery.
Incidence of postoperative functional decline. Change from preoperative baseline postoperative functional decline to postoperative 12 months.
Measured: Change from baseline through one year
Determine the effects of intravenous vs. inhalational anesthesia on patient-reported outcomes (PROMIS-29+2 Profile v2.1) in older adults undergoing non-cardiac surgery.
patient-reported outcome scores, PROMIS-29+2 Profile v2.1 (PROPr) assesses patient-reported measures of anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, participation in social activities, pain, and cognition. Measured at preoperative baseline, 3 months postoperatively, and 12 months postoperatively
Measured: Change from baseline through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start14 Aug 2023
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This single-center, 1:1 randomized, double-blind (patient \& outcome assessor) clinical trial will compare inhalational (sevoflurane) vs. intravenous (propofol) anesthesia on POD, POCD, functional status, PROs, and biomarkers in patients ≥ 70 years undergoing elective, inpatient, non-cardiac surgery at Oregon Health \& Science University.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie J. Schenning, Oregon Health and Science University
- Investigators
- Katie J. Schenning, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036095
- Sponsor's protocol ID
- STUDY00024667
- Acronym
- TIVA GAS
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to promote advancement of this field of study, we will make data generated from this project available. Participants will sign a data repository consent form so de-identified data is able to be maintained indefinitely on secure servers at Oregon Health \& Science University. This will enable us to combine these data with other datasets for future analyses, and to share with collaborators and other interested scientists. Other researchers would sign a data use agreement and then receive the de-identified data requested.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Anesthesia to Prevent Postoperative Cognitive and Functional Decline in Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06036095
- Acronym / sponsor ID
- TIVA GAS / STUDY00024667
- Conditions
- Neurocognitive Disorders, Anesthesia, Post-operative Delirium, Post-operative Cognitive Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 13 Sep 2023 (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.
Traditionally, general anesthesia is maintained with inhalational anesthesia (GAS), but there is a gap in knowledge regarding whether intravenous anesthesia (IV) can prevent deleterious postoperative outcomes in the geriatric surgical population. The goal of this clinical trial is to determine whether intravenous anesthesia (IV) leads to a decreased incidence of postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and functional decline, and improved patient-reported outcomes (PROs) in older adults undergoing non-cardiac surgery when compared to the standard inhalational anesthesia (GAS). This single-center, 1:1 randomized, double-blind (patient \& outcome assessor) clinical trial will compare inhalational vs. intravenous anesthesia on POD, POCD, functional status, patient-reported outcomes (PROs), and blood-based biomarkers in older patients undergoing elective, inpatient, non-cardiac surgery. Upon enrollment, 260 women and men ≥ 70 years undergoing elective noncardiac surgery under general anesthesia will be randomized to 2 groups: TIVA or GAS.
Detailed description
Aim 1: Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium and postoperative cognitive dysfunction in older adults undergoing non-cardiac surgery.
Hypothesis: Intravenous anesthesia is associated with a lower incidence of POD and POCD compared to inhalational anesthesia.
Primary outcomes: Incidence of postoperative delirium and postoperative cognitive dysfunction Secondary outcomes: delirium severity, delirium duration Aim 2: Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline and patient-reported outcomes in older adults undergoing non-cardiac surgery.
Hypothesis: Intravenous anesthesia is associated with a lower incidence of postoperative functional decline and improved patient-reported outcomes (PROs) compared to inhalational anesthesia.
Primary outcomes: Incidence of postoperative functional decline; patient-reported outcome scores Aim 3: Determine the effects of intravenous vs. inhalational anesthesia on blood phosphorylated tau 181 (p-tau181) and other blood biomarkers in older adults undergoing non-cardiac surgery.
Hypothesis 1: Elevated preop blood p-tau181 is associated with increased POD and POCD; Hypothesis 2: Postoperative increase in blood p-tau181 is greater with GAS relative to IV; Hypothesis 3: Postop increases in blood biomarkers of neuroinflammation and AD pathology are greater with GAS relative to IV.
Primary outcomes: preoperative levels of blood p-tau181 and change in levels from preoperative baseline to postoperative.
Secondary outcomes: Other candidate biomarkers include those previously implicated in POD or POCD: p-tau217, Aβ,54 NF-L,55 High mobility group box protein 1 (HMGB1),60 S100β,76 interleukin (IL)-6,58 IL-1β,22 IL-10,46 tumor necrosis factor (TNF)-α,22 CCL2,62 and glial fibrillary acidic protein (GFAP).77
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This single-center, 1:1 randomized, double-blind (patient \& outcome assessor) clinical trial will compare inhalational (sevoflurane) vs. intravenous (propofol) anesthesia on POD, POCD, functional status, PROs, and biomarkers in patients ≥ 70 years undergoing elective, inpatient, non-cardiac surgery at Oregon Health \& Science University.
| Arm | Type | Receives |
|---|---|---|
| Inhalational Anesthesia | Active comparator | Drug: SevofluraneInhalational maintenance of anesthesia group using sevoflurane |
| Intravenous Anesthesia | Active comparator | Drug: PropofolIntravenous maintenance of anesthesia group using propofol |
Who may qualify
- Ages
- 70 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Men and women ≥ 70 years
- Sufficient vision and hearing to complete all tests
- Proficient in spoken and written English
- Scheduled for elective, inpatient, noncardiac surgery, expected to last at least 120 minutes requiring general anesthesia
Key exclusion criteria (11 listed)
- Urgent or emergent surgery
- Diagnosed dementia (or MoCA<19)
- History of Parkinson's disease, major psychiatric disease (Schizophrenia), or severe traumatic brain injury
- Ongoing alcohol or substance abuse (per DSM V criteria)
- Allergy to propofol or sevoflurane
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 |
|---|---|---|
| SevofluraneAlso: Inhalational AnesthesiaInhalational maintenance of anesthesia group using sevoflurane | Drug | Inhalational Anesthesia |
| PropofolAlso: Intravenous AnesthesiaIntravenous maintenance of anesthesia group using propofol | Drug | Intravenous Anesthesia |
Primary outcome
Effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium in older surgical patients with the 3D-Confusion Assessment Method (3D-CAM-S) and the CAM-ICU-7.
Time frame: through postoperative day 3
Incidence of postoperative delirium with the 3D-Confusion Assessment Method (3D-CAM) in non-intubated patients and the CAM-ICU-7 in intubated patients. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3 while the patient is in the hospital.
Determine the effects of intravenous vs. inhalational anesthesia on the incidence of postoperative neurocognitive disorder in older adults undergoing non-cardiac surgery using neuropsychiatric composite score.
Time frame: Change from preoperative baseline to one year.
Postoperative neurocognitive disorder. Change from preoperative baseline cognitive dysfunction using neuropsychiatric composite score. Battery of neuropsychological tests: Animal Verbal Fluency Test, Trail Making Test A \& B, Digit Symbol Test, Logical Memory Immediate \& Delayed Recall, and CERAD Word List Immediate and Delayed recall. MASQ will be used for subjective cognitive decline. Functional status will be measured by FAQ.
4 secondary outcomes
Determine the effects of intravenous vs. inhalational anesthesia on incidence of delirium duration (days) and severity, measured by 3D-CAM-S, and CAM-ICU-7 in older adults undergoing non-cardiac surgery.
Time frame: through postoperative day 3
Effects of intravenous vs. inhalational anesthesia on levels of blood phosphorylated tau 181 (p-tau181) in older surgical patients.. Change from preoperative baseline blood p-tau181 to postoperative day 1, 3 months and 12 months.
Time frame: Change from baseline through one year.
Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline using ADL, FAQ, and FRAIL in older adults undergoing non-cardiac surgery.
Time frame: Change from baseline through one year
Determine the effects of intravenous vs. inhalational anesthesia on patient-reported outcomes (PROMIS-29+2 Profile v2.1) in older adults undergoing non-cardiac surgery.
Time frame: Change from baseline through one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: Yes. In order to promote advancement of this field of study, we will make data generated from this project available. Participants will sign a data repository consent form so de-identified data is able to be maintained indefinitely on secure servers at Oregon Health \& Science University. This will enable us to combine these data with other datasets for future analyses, and to share with collaborators and other interested scientists. Other researchers would sign a data use agreement and then receive the de-identified data requested.
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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.
Katie J. Schenning, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Propofol in people with Neurocognitive Disorders and Anesthesia, run by Oregon Health and Science University 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 Apr 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly N. Chun, BS (503-494-7437, chunk@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium in older surgical patients with the 3D-Confusion Assessment Method (3D-CAM-S) and the CAM-ICU-7. (time frame: through postoperative day 3). The study lists 2 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 8 Apr 2024.