Healthy VolunteersPhase 1IDEANCT07198711
Induction of Dreaming With EEG and Anesthesia in Healthy Adults
A Phase 1 study testing Propofol - Emergence-from-LOR Protocol and Propofol - Light Sedation Protocol in people with Healthy Volunteers, run by Stanford University at 1 site in United States.
Trial summary
This open-label, randomized crossover study in healthy adults tests two propofol protocols to produce distinct experiential states. One induces brief loss of responsiveness with spontaneous emergence, intended to elicit dream reports; the other maintains light sedation without loss of responsiveness, intended to… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Propofol - Emergence-from-LOR Protocol and Propofol - Light Sedation Protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to 31 May 2027
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 70 years of age, inclusive, at screen.
- Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
- In sufficiently good health to proceed with a low risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class 1 or 2.
- If female, a status of non-childbearing potential or use of an acceptable form of birth control
- Body mass index between 17-35 kg/m2.
Who cannot join
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
- Female that is pregnant or breastfeeding.
- Female with a positive pregnancy test at screening or baseline.
- Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe", or Alcohol Use Disorder rated "moderate" or "severe". The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (>12 months) time frames.
- Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder
- History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms
Show all 40Show fewer
- History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
- In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study.
- A neurological disorder including:
- Has dementia, delirium, amnestic, or any other cognitive disorder.
- Lifetime history of surgical procedures involving the brain or meninges,
- encephalitis, meningitis, degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation
- any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system (CNS),
- history of significant head trauma within the past two years.
- A cardiovascular disorder including:
- uncontrolled hypertension
- Congestive heart failure NYHA Criteria >Stage 2
- Atrial fibrillation or resting heart rate <50 or >105 beats per minute at screening or randomization
- Any conduction abnormalities including AV nodal block of any type or intraventricular conduction delay.
- QTcF (Fridericia-corrected) >= 450 msec at screening or randomization
- any cardiovascular disorder that would merit categorization of patient as ASA Class 3 or higher
- A pulmonary/respiratory disorder including:
- diagnosed Obstructive Sleep Apnea or STOPBANG score of 3 or higher
- History of difficult airway in surgical setting
- any pulmonary / respiratory disorder that would merit categorization of patient as ASA Class 3 or higher
- Clinically significant liver disease, determined by LFTs within the past 6 months.
- Clinically significant kidney disease determined by creatinine / GFR within the past 6 months.
- Symptomatic gastroesophageal reflux disease, hiatal hernia, or other gastrointestinal disorder placing patient at risk for aspiration or that would merit categorization of patient as ASA Class 3 or higher
- Any endocrine disorder including:
- uncontrolled diabetes, type 1 or 2
- History of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months prior to screening. (Subjects on a stable dosage of thyroid replacement medication for at least six months or more prior to screening are eligible for enrollment.)
- History of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening.
- Other endocrine disorder that would merit categorization of patient as ASA Class 3 or higher
- Patients taking any of the following daily medications:
- opioids including buprenorphine and methadone
- naltrexone or other opioid antagonist
- clonidine
- Any other clinically significant abnormal laboratory result at the time of the screening exam.
- Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation or confound interpretation of study results, including any condition that would merit categorization of patient as ASA Class 3 or higher.
- Participation in any clinical trial with an investigational drug or device that conflicts with this trial, within the past month or concurrent to study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Ketamine Versus Saline During Sedation in Patients With Major Depressive Disorder: a Double-blind Trial
This open-label, randomized crossover study in healthy adults tests two propofol protocols to produce distinct experiential states. One induces brief loss of responsiveness with spontaneous emergence, intended to elicit dream reports; the other maintains light sedation without loss of responsiveness, intended to elicit non-dream experiences while participants remain responsive. The main goals are to (a) measure the protocol-concordant experiential report rate (how often each method produces its intended experience), (b) explore EEG correlates of these experiences in the two states, and (c) describe their phenomenology (what they are like). We will also examine short-term changes in well-being and sleep related to these experiences. Participants complete four sessions (two of each method) with EEG and routine monitoring, immediate post-session interviews, and brief questionnaires and daily sleep/dream logs before and after anesthesia sessions.
- Conditions
- Healthy Volunteers
- Being tested
- Propofol - Emergence-from-LOR Protocol, Propofol - Light Sedation Protocol
- Keywords
- anesthesia, propofol, dreaming, consciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol - Emergence-from-LOR ProtocolDrug
Intravenous propofol infusion that meets the criteria: (1) maintenance of spontaneous ventilation, (2) sedation level corresponding to a Patient State Index (PSI) no lower than 25; and (3) loss of responsiveness (LOR) defined by the Richmond Agitation Sedation Scale (RASS) = -5 [unarousable]. Anesthesia is then maintained at that level for 30 minutes, followed by spontaneous emergence.
Propofol - Light Sedation ProtocolDrug
Intravenous propofol infusion titrated stepwise to reach a state where participants are sedated but have behavioral responsiveness. Sedation is maintained at this level for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Emergence-from-LOR Protocol | Experimental | Participants receive propofol titrated to loss of responsiveness (LOR) followed by maintenance and spontaneous emergence. This protocol is designed to elicit dream reports upon emergence (i.e., reports of subjective experiences occurring during the unresponsiveness period) Receives: Drug: Propofol - Emergence-from-LOR Protocol |
| No-LOR Light Sedation Protocol | Experimental | Participants receive propofol titrated stepwise to light sedation without LOR, maintaining responsiveness. This protocol is designed to elicit non-dream experiential reports while responsive (e.g., simple imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences). Receives: Drug: Propofol - Light Sedation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol-concordant experiential report
Presence vs absence of an experiential report elicited via a structured interview (modified Brice). "Protocol-concordant" is defined as:
LOR protocol-success = any dream report upon emergence; Light-sedation (no-LOR) protocol-success = any experiential report that is not a dream (e.g., imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences) while the participant remained behaviorally responsive.
Measured: Assessed within 5 minutes of return of responsiveness (LOR protocol) or within 5 minutes of session end (light-sedation protocol).
Secondary outcomes (18)
EEG correlates of protocol-concordant experiential outcome
EEG correlates of the two protocols/states, examining spectral band powers, band ratios, and other features during the matched windows and their association with protocol-concordant experiential outcomes.
Measured: Matched-duration EEG windows during the 30-minute maintenance period: pre-emergence window prior to return of responsiveness in the LOR protocol, and a time-matched window during maintenance in the no-LOR protocol.
Phenomenology of anesthesia experiences (analysis of narrative reports)
Transcriptions of audio-interviews and analysis of these using (i) codebook-based content analysis, (ii) phenomenological thematic/structural coding, and (iii) NLP-derived text features.
Measured: Interview immediately post-session
Phenomenology of anesthesia experiences (self-ratings)
Participants' own ratings of their anesthesia experiences: complexity, vividness, affect (valence/intensity), meaningfulness, dynamism/movement, bizarreness, perceived duration, the degree of mystical experiences (Mystical Experience Questionnaire; Barrett et al., 2015) and challenging experiences (Challenging Experience Questionnaire; Strickland et al., 2024).
Measured: Interview immediately post-session
Dream vs dream-like experiences (within-anesthesia) - phenomenological differences
Comparison of phenomenology between anesthesia dreams (LOR protocol) and dream-like experiences (light sedation no-LOR protocol) based on the analysis of narrative reports and self-ratings of the experiences
Measured: Interview immediately post-session
Home dreams vs anesthesia dreams - phenomenological differences
Differences in phenomenology of home dreams vs anesthesia dreams based on the analysis of narrative reports and self-ratings of these experiences
Measured: Home dream logs (2 weeks pre-session and 2 weeks post-session) vs anesthesia interview (immediate post-session).
Safety outcomes
Incidence of adverse events during anesthesia or recovery (e.g., PONV; hypoxemia; hypotension; airway intervention) and any serious adverse events per FDA criteria.
Measured: From pre-anesthesia baseline to post-anesthesia discharge
Changes in daily mood
As measured with the following mood scales: PANAS (Watson et al., 1988) and items from the 12-point Affect Circumplex (Yik et al., 2011)
Measured: Baseline (2-week pre-session average) to follow-up (2-week post-session average)
Change in well-being: life satisfaction
As measured with The Satisfaction With Life Scale (Diener et al., 1985)
Measured: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in well-being: peace of mind
As measured with The Peace of Mind Scale (Lee et al., 2013)
Measured: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in sleep quality
Change in sleep quality as measured using the Pittsburgh Sleep Quality Inventory (PSQI; Buysse et al., 1989) and daily sleep and dream diaries
Measured: Baseline (2-week pre-session) to follow-up (2-week post-session)
Change in dream outcomes
Change in dream recall frequency, occurrence of nightmares, nightmare distress as measured using the Mannheim Dream Questionnaire (MADRE; Schredl et al., 2014) and daily dream diaries
Measured: Baseline (2-week pre-session) to follow-up (2-week post-session).
Change in well-being: harmony in life
As measured with the Harmony in Life Scale (Kjell et al., 2016)
Measured: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in well-being: psychological (eudaimonic) well-being
As measured with the Psychological Well-Being Scale (Ryff, 1989)
Measured: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in alexithymia score
As measured with the Perth Alexithymia Questionnaire Short Form (Preece et al., 2023)
Measured: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in emotion regulation
As measured with the Emotion Regulation Questionnaire (Gross \& John, 2003) and the Perth Emotion Regulation Competency Index (Preece et al., 2018)
Measured: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in symptoms of depression
As measured with the depression module of the Patient Health Questionnaire (PHQ9; Spitzer et al., 1999)
Measured: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in symptoms of anxiety
As measured with the The Generalized Anxiety Disorder Scale (GAD-9; Spitzer et al., 2006)
Measured: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in perceived loneliness
As measured the 3-item UCLA Loneliness Scale (Hughes et al., 2004)
Measured: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start20 May 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Tiny Blue Dot Foundation
- Responsible party
- Principal investigator, Boris D. Heifets, Stanford University
- Investigators
- Dr. Boris D Heifets, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198711
- Sponsor's protocol ID
- 55215
- Acronym
- IDEA
- Status last verified
- Jun 2026
- First submitted
- 14 Sep 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifiers might be removed from identifiable private information and/or identifiable specimens and, after such removal, the information and/or specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the participant. The results of this research study may be presented at scientific or medical meetings or published in scientific journals without disclosing the identify of the participants (unless there is a separate consent from participants to reveal their identity).
Publications
Chow HS, Hack LM, Kawai M, Heifets BD. Anesthetic-Induced Intraoperative Dream Associated With Remission of a Psychiatric Disorder: A Case Report. A A Pract. 2022 Aug 10;16(8):e01613. doi: 10.1213/XAA.0000000000001613. eCollection 2022 Aug 1.
PubMed 35952341Hack LM, Sikka P, Zhou K, Kawai M, Chow HS, Heifets B. Reduction in Trauma-Related Symptoms After Anesthetic-Induced Intra-Operative Dreaming. Am J Psychiatry. 2024 Jun 1;181(6):563-564. doi: 10.1176/appi.ajp.20230698. Epub 2024 Mar 13. No abstract available.
PubMed 38476046
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ketamine Versus Saline During Sedation in Patients With Major Depressive Disorder: a Double-blind Trial
- ClinicalTrials.gov ID
- NCT07198711
- Acronym / sponsor ID
- IDEA / 55215
- Conditions
- Healthy Volunteers
- Keywords
- anesthesia, propofol, dreaming, consciousness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Tiny Blue Dot Foundation
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Sep 2025 (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 open-label, randomized crossover study in healthy adults tests two propofol protocols to produce distinct experiential states. One induces brief loss of responsiveness with spontaneous emergence, intended to elicit dream reports; the other maintains light sedation without loss of responsiveness, intended to elicit non-dream experiences while participants remain responsive. The main goals are to (a) measure the protocol-concordant experiential report rate (how often each method produces its intended experience), (b) explore EEG correlates of these experiences in the two states, and (c) describe their phenomenology (what they are like). We will also examine short-term changes in well-being and sleep related to these experiences. Participants complete four sessions (two of each method) with EEG and routine monitoring, immediate post-session interviews, and brief questionnaires and daily sleep/dream logs before and after anesthesia sessions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergence-from-LOR Protocol | Experimental | Drug: Propofol - Emergence-from-LOR ProtocolParticipants receive propofol titrated to loss of responsiveness (LOR) followed by maintenance and spontaneous emergence. This protocol is designed to elicit dream reports upon emergence (i.e., reports of subjective experiences occurring during the unresponsiveness period) |
| No-LOR Light Sedation Protocol | Experimental | Drug: Propofol - Light Sedation ProtocolParticipants receive propofol titrated stepwise to light sedation without LOR, maintaining responsiveness. This protocol is designed to elicit non-dream experiential reports while responsive (e.g., simple imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18 to 70 years of age, inclusive, at screen.
- Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
- In sufficiently good health to proceed with a low risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class 1 or 2.
- If female, a status of non-childbearing potential or use of an acceptable form of birth control
- Body mass index between 17-35 kg/m2.
Key exclusion criteria (40 listed)
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
- Female that is pregnant or breastfeeding.
- Female with a positive pregnancy test at screening or baseline.
- Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe", or Alcohol Use Disorder rated "moderate" or "severe". The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (>12 months) time frames.
- Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder
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 |
|---|---|---|
| Propofol - Emergence-from-LOR ProtocolIntravenous propofol infusion that meets the criteria: (1) maintenance of spontaneous ventilation, (2) sedation level corresponding to a Patient State Index (PSI) no lower than 25; and (3) loss of responsiveness (LOR) defined by the Richmond Agitation Sedation Scale (RASS) = -5 [unarousable]. Anesthesia is then maintained at that level for 30 minutes, followed by spontaneous emergence. | Drug | Emergence-from-LOR Protocol |
| Propofol - Light Sedation ProtocolIntravenous propofol infusion titrated stepwise to reach a state where participants are sedated but have behavioral responsiveness. Sedation is maintained at this level for 30 minutes. | Drug | No-LOR Light Sedation Protocol |
Primary outcome
Protocol-concordant experiential report
Time frame: Assessed within 5 minutes of return of responsiveness (LOR protocol) or within 5 minutes of session end (light-sedation protocol).
Presence vs absence of an experiential report elicited via a structured interview (modified Brice). "Protocol-concordant" is defined as: LOR protocol-success = any dream report upon emergence; Light-sedation (no-LOR) protocol-success = any experiential report that is not a dream (e.g., imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences) while the participant remained behaviorally responsive.
18 secondary outcomes
EEG correlates of protocol-concordant experiential outcome
Time frame: Matched-duration EEG windows during the 30-minute maintenance period: pre-emergence window prior to return of responsiveness in the LOR protocol, and a time-matched window during maintenance in the no-LOR protocol.
Phenomenology of anesthesia experiences (analysis of narrative reports)
Time frame: Interview immediately post-session
Phenomenology of anesthesia experiences (self-ratings)
Time frame: Interview immediately post-session
Dream vs dream-like experiences (within-anesthesia) - phenomenological differences
Time frame: Interview immediately post-session
Home dreams vs anesthesia dreams - phenomenological differences
Time frame: Home dream logs (2 weeks pre-session and 2 weeks post-session) vs anesthesia interview (immediate post-session).
Safety outcomes
Time frame: From pre-anesthesia baseline to post-anesthesia discharge
Changes in daily mood
Time frame: Baseline (2-week pre-session average) to follow-up (2-week post-session average)
Change in well-being: life satisfaction
Time frame: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in well-being: peace of mind
Time frame: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in sleep quality
Time frame: Baseline (2-week pre-session) to follow-up (2-week post-session)
Change in dream outcomes
Time frame: Baseline (2-week pre-session) to follow-up (2-week post-session).
Change in well-being: harmony in life
Time frame: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in well-being: psychological (eudaimonic) well-being
Time frame: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in alexithymia score
Time frame: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in emotion regulation
Time frame: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in symptoms of depression
Time frame: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in symptoms of anxiety
Time frame: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
Change in perceived loneliness
Time frame: Baseline (2-weeks pre-anesthesia) to follow-up (2-weeks post-anesthesia)
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 22 Jun 2026.
- Background: PubMed 35952341Chow HS, Hack LM, Kawai M, Heifets BD. Anesthetic-Induced Intraoperative Dream Associated With Remission of a Psychiatric Disorder: A Case Report. A A Pract. 2022 Aug 10;16(8):e01613. doi: 10.1213/XAA.0000000000001613. eCollection 2022 Aug 1.
- Background: PubMed 38476046Hack LM, Sikka P, Zhou K, Kawai M, Chow HS, Heifets B. Reduction in Trauma-Related Symptoms After Anesthetic-Induced Intra-Operative Dreaming. Am J Psychiatry. 2024 Jun 1;181(6):563-564. doi: 10.1176/appi.ajp.20230698. Epub 2024 Mar 13. No abstract available.
- Individual participant dataSharing planned: Yes. Identifiers might be removed from identifiable private information and/or identifiable specimens and, after such removal, the information and/or specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the participant. The results of this research study may be presented at scientific or medical meetings or published in scientific journals without disclosing the identify of the participants (unless there is a separate consent from participants to reveal their identity).
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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.
Dr. Boris D Heifets, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propofol - Emergence-from-LOR Protocol and Propofol - Light Sedation Protocol in people with Healthy Volunteers, run by Stanford 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 5 inclusion and 40 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: enrolling by invitation, as of the sponsor's last update on 22 Jun 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Protocol-concordant experiential report (time frame: Assessed within 5 minutes of return of responsiveness (LOR protocol) or within 5 minutes of session end (light-sedation protocol).). 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 NCT07198711, which also lists 2 linked publications.
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 22 Jun 2026.