Emergence From AnesthesiaPhase 1NCT04942340
Turning Dexmedetomidine Into a Powerful Anesthetic That Can be Rapidly and Completely Reversed
A Phase 1 study testing Atipamezole & Caffeine and Dexmedetomidine Hydrochloride & Saline in people with Emergence From Anesthesia, run by University of Chicago at 1 site in United States.
Trial summary
In this study, the investigators will explore Atipamezole \& caffeine's ability to facilitate the emergence from anesthesia. Each subject will visit UChicago 4 times. The first time for informed consent. The second time for a complete physical exam to ensure that the subjects are healthy. Read more about this study
- Who is it for?
- Ages 22 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence From Anesthesia
- What is being tested?
- Atipamezole & Caffeine and Dexmedetomidine Hydrochloride & Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2023to May 2026
- Phase
- Phase 1
- 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 22 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >21 or <40
- ASA physical status = 1 (normal healthy patient without systematic diseases or conditions)
- Metabolic Equivalents of Functional Capacity (METs) > 5
- Low risk for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to < 3 items- high risk of OSA
- No history Arrhythmia, such as heart block (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
- BMI <30 kg/m2
- No history of any mental illness
- No history of drugs or alcohol abuse (an urine drug screen test required)
Who cannot join
- Age <21 or >40
- ASA physical status > 1 (normal healthy patient with systematic diseases or conditions)
- Metabolic Equivalents of Functional Capacity (METs)<5
- High risks for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to > 3 items- high risk of OSA
- History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
- BMI >30 kg/m2
Show all 9Show fewer
- History of any mental illness
- History of drugs or alcohol abuse (an urine drug screen test required)
- Female subjects with positive urine pregnancy test, which will be performed before each sedation session
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
In this study, the investigators will explore Atipamezole \& caffeine's ability to facilitate the emergence from anesthesia. Each subject will visit UChicago 4 times. The first time for informed consent. The second time for a complete physical exam to ensure that the subjects are healthy. Then there are 2 sedation sessions. Subjects get an honorarium for each sedation session.
Read the detailed description
Each subject will attend 3 sessions to complete the study. In the first session, an anesthesiologist will take a medical history and perform a physical examination on the subject. A baseline EKG and urine drug screen test will be obtained. If the subject meets the criteria for the study, healthy and drug-free, the risks involved in the study will be covered in detail. If the subject is willing, then that subject will be enrolled in the study and a detailed informed consent form will covered in detail. Prior to signing the consent form the subject will be required to describe the risks involved in the study in their own words, showing that each subject understand. For each session, subjects will be asked not to eat and drink 8 hours prior to the study in order to minimize the potential risk for aspiration during anesthesia
Once the subject is checked in, a peripheral intravenous catheter (IV) will be inserted on one of the arms. A second IV will be inserted to the other arm. After the IV insertion, American Society of Anesthesiologists (ASA) standard monitoring, including EKG, blood pressure (BP), respiratory rate, pulse oximetry and temperature, will be used to assess the subject. An EEG monitor probe will be applied to the forehead skin as well. The subject will then be asked to breathe 100% reof Precedex (2 g/kg), via pump, across 10 minutes. There will be a 5 minute interval to allow the drug to equilibrate. Then p or saline (control). The face mask will stay in place throughout the procedure. For the experiment described, Ati: Dex ratio is 1:1. The investigators will be blind to the injection.
The investigators will measure the time when the drug injections are complete to the awakening of the subject. The investigators will record the time until the subject's eyes open, and the time until the subject can respond to the command to grip the hand of the attending physician. When the subject is awake and alert (oriented to time, place and name), the subject will perform psychomotor tests to measure his cognitive function. The subject will be required to complete a simple set of cognitive tests to determine if they are still impaired by the sedative. Both "control" and test subjects will be required to complete the same tests. Tests include one for hand-eye coordination by tracking a randomly moving circle on a computer screen with a cross controlled by a mouse. Reaction time is measured by asking the subject to press a button when the subject hears a sound. The tests will be repeated every 15 minutes for 90 minutes after waking. This will allow the investigators to get a recovery time course.
- Conditions
- Emergence From Anesthesia
- Being tested
- Atipamezole & Caffeine, Dexmedetomidine Hydrochloride & Saline
- Keywords
- Atipamezole, Caffeine, Sedation Recovery, Anesthesia, Precedex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atipamezole & CaffeineDrug
Also called Antisedan
In this arm, subjects will be infused with Atipamezole (2 g/kg) and caffeine (15 mg/kg) across 5 minutes
Dexmedetomidine Hydrochloride & SalineDrug
Also called Precedex
In this arm, subjects will be infused with Precedex \& Saline at 15 mg/kg across 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Atipamezole & caffeine's in a 1:1 ratio | Active comparator | Is this arm, subjects will be randomized to IV administration of Atipamezole \& caffeine's in a 1:1 ratio Receives: Drug: Atipamezole & Caffeine |
| Phase 1: Precedex & Saline in a 1:1 ratio | Placebo comparator | Is this arm, subjects will be randomized to receive IV administration of Precedex \& Saline in a 1:1 ratio Receives: Drug: Dexmedetomidine Hydrochloride & Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time when the drug injections are complete to the awakening of the subject.
We will record the time until the subject's eyes open, and the time until the subject can respond to the command to grip the hand of the attending physician
Measured: 1 Day
Secondary outcomes (2)
Measure Cognitive Function
Subjects will be asked to track randomly moving circle on a computer screen with a cross controlled by a mouse
Measured: This test will be repeated every 15 Minutes for 90 Minutes after the subject has awakened]
Measure Reaction Time
Subjects will be asked to press a button when he/ she hears a sound
Measured: This test will be repeated every 15 Minutes for 90 Minutes after the subject has awakened]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study startMay 2023 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: Withdrawn secondary to a change in protocol design forthcoming.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence From AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TBA
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942340
- Sponsor's protocol ID
- IRB21-0922
- Status last verified
- May 2023
- First submitted
- 11 Jun 2021
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turning Dexmedetomidine Into a Powerful Anesthetic That Can be Rapidly and Completely Reversed
- ClinicalTrials.gov ID
- NCT04942340
- Acronym / sponsor ID
- IRB21-0922
- Conditions
- Emergence From Anesthesia
- Keywords
- Atipamezole, Caffeine, Sedation Recovery, Anesthesia, Precedex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn secondary to a change in protocol design forthcoming.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 28 Jun 2021 (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.
In this study, the investigators will explore Atipamezole \& caffeine's ability to facilitate the emergence from anesthesia. Each subject will visit UChicago 4 times. The first time for informed consent. The second time for a complete physical exam to ensure that the subjects are healthy. Then there are 2 sedation sessions. Subjects get an honorarium for each sedation session.
Detailed description
Each subject will attend 3 sessions to complete the study. In the first session, an anesthesiologist will take a medical history and perform a physical examination on the subject. A baseline EKG and urine drug screen test will be obtained. If the subject meets the criteria for the study, healthy and drug-free, the risks involved in the study will be covered in detail. If the subject is willing, then that subject will be enrolled in the study and a detailed informed consent form will covered in detail. Prior to signing the consent form the subject will be required to describe the risks involved in the study in their own words, showing that each subject understand. For each session, subjects will be asked not to eat and drink 8 hours prior to the study in order to minimize the potential risk for aspiration during anesthesia
Once the subject is checked in, a peripheral intravenous catheter (IV) will be inserted on one of the arms. A second IV will be inserted to the other arm. After the IV insertion, American Society of Anesthesiologists (ASA) standard monitoring, including EKG, blood pressure (BP), respiratory rate, pulse oximetry and temperature, will be used to assess the subject. An EEG monitor probe will be applied to the forehead skin as well. The subject will then be asked to breathe 100% reof Precedex (2 g/kg), via pump, across 10 minutes. There will be a 5 minute interval to allow the drug to equilibrate. Then p or saline (control). The face mask will stay in place throughout the procedure. For the experiment described, Ati: Dex ratio is 1:1. The investigators will be blind to the injection.
The investigators will measure the time when the drug injections are complete to the awakening of the subject. The investigators will record the time until the subject's eyes open, and the time until the subject can respond to the command to grip the hand of the attending physician. When the subject is awake and alert (oriented to time, place and name), the subject will perform psychomotor tests to measure his cognitive function. The subject will be required to complete a simple set of cognitive tests to determine if they are still impaired by the sedative. Both "control" and test subjects will be required to complete the same tests. Tests include one for hand-eye coordination by tracking a randomly moving circle on a computer screen with a cross controlled by a mouse. Reaction time is measured by asking the subject to press a button when the subject hears a sound. The tests will be repeated every 15 minutes for 90 minutes after waking. This will allow the investigators to get a recovery time course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- TBA
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Atipamezole & caffeine's in a 1:1 ratio | Active comparator | Drug: Atipamezole & CaffeineIs this arm, subjects will be randomized to IV administration of Atipamezole \& caffeine's in a 1:1 ratio |
| Phase 1: Precedex & Saline in a 1:1 ratio | Placebo comparator | Drug: Dexmedetomidine Hydrochloride & SalineIs this arm, subjects will be randomized to receive IV administration of Precedex \& Saline in a 1:1 ratio |
Who may qualify
- Ages
- 22 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age >21 or <40
- ASA physical status = 1 (normal healthy patient without systematic diseases or conditions)
- Metabolic Equivalents of Functional Capacity (METs) > 5
- Low risk for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to < 3 items- high risk of OSA
- No history Arrhythmia, such as heart block (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
Key exclusion criteria (9 listed)
- Age <21 or >40
- ASA physical status > 1 (normal healthy patient with systematic diseases or conditions)
- Metabolic Equivalents of Functional Capacity (METs)<5
- High risks for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to > 3 items- high risk of OSA
- History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
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 |
|---|---|---|
| Atipamezole & CaffeineAlso: AntisedanIn this arm, subjects will be infused with Atipamezole (2 g/kg) and caffeine (15 mg/kg) across 5 minutes | Drug | Phase 1: Atipamezole & caffeine's in a 1:1 ratio |
| Dexmedetomidine Hydrochloride & SalineAlso: PrecedexIn this arm, subjects will be infused with Precedex \& Saline at 15 mg/kg across 5 minutes | Drug | Phase 1: Precedex & Saline in a 1:1 ratio |
Primary outcome
The time when the drug injections are complete to the awakening of the subject.
Time frame: 1 Day
We will record the time until the subject's eyes open, and the time until the subject can respond to the command to grip the hand of the attending physician
2 secondary outcomes
Measure Cognitive Function
Time frame: This test will be repeated every 15 Minutes for 90 Minutes after the subject has awakened]
Measure Reaction Time
Time frame: This test will be repeated every 15 Minutes for 90 Minutes after the subject has awakened]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: Undecided
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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 Phase 1 study testing Atipamezole & Caffeine and Dexmedetomidine Hydrochloride & Saline in people with Emergence From Anesthesia, run by University of Chicago 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 8 inclusion and 9 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: withdrawn, as of the sponsor's last update on 17 May 2023. 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The time when the drug injections are complete to the awakening of the subject. (time frame: 1 Day). 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 17 May 2023.