AnesthesiaPhase 4NCT03360903
A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia
A Phase 4 study testing Caffeine in people with Anesthesia, run by University of Chicago at 1 site in United States.
Trial summary
At present clinicians have no way to reverse anesthesia. Patients wake when their bodies clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and other cognitive problems after waking from anesthesia. Read more about this study
- Who is it for?
- Ages 25 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Caffeine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 1 Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25-40.
- Male.
- Normal healthy subject without systematic diseases or conditions.
- Metabolic Equivalents of Functional Capacity >= 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 of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases.
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- BMI < 30 kg/m2.
- No history of prior difficulty with anesthesia.
- No personal or family history of malignant hyperthermia.
- No history of any mental illness.
- No history of drugs or alcohol abuse (urine drug screens required).
- Subjects capable of giving consent.
- Living less than 30 miles away from University of Chicago.
- No history of seizure disorders.
- No history of head trauma.
Who cannot join
- Age <25 or >40.
- Female.
- ASA physical status > 1 (normal healthy subject without 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
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- BMI>30 kg/m2.
- Prior difficulty with anesthesia.
- Personal or family history of malignant hyperthermia.
- History of any mental illness.
- History of drugs or alcohol abuse (urine drug screens required)
- Subjects not capable of giving consent
- Living more than 30 miles away from University of Chicago.
- History of seizure disorders.
- History of head trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study to Determine if Caffeine Citrate Accelerates Emergence From Anesthesia
At present clinicians have no way to reverse anesthesia. Patients wake when their bodies clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and other cognitive problems after waking from anesthesia. In studies on animals, the investigators observed that caffeine caused rats to wake much more rapidly from propofol anesthesia. This was true for all the animals tested. The investigators would like to see if this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse the cognitive deficits associated with anesthesia, after waking?
The propose investigators carrying out a modest trial with 8 test subjects. Each volunteer will be anesthetized twice. Each volunteer will be anesthetized one time and receive an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer will receive an infusion of a relatively low dose of caffeine. The order of saline versus caffeine will be randomized and the study will be done in a double blind manner. We will determine whether emergence from propofol anesthesia will be significantly accelerated by the caffeine infusion. And whether any adverse events are observed.
- Conditions
- Anesthesia
- Being tested
- Placebo, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
Other Names:
- Saline
CaffeineDrug
Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
Other Names:
- Caffeine citrate
| Study group | Role | What they receive |
|---|---|---|
| Placebo then Caffeine | Experimental | Anesthetized volunteers will be allowed to wake after injection of saline (placebo control) followed by a washout period and then anesthetized again and allowed to wake after injection of caffeine (15 mg/ kg). Receives: Drug: Placebo; Drug: Caffeine |
| Caffeine then Placebo | Experimental | Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg) followed by a washout period and then anesthetized again and allowed to wake after injection of saline (placebo control). Receives: Drug: Placebo; Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes.
The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject opening their eyes will be measured. The time to "emerge" from anesthesia will be defined as the time between terminating the anesthesia and the test subject opening their eyes.
Measured: 15 minutes
Secondary outcomes (6)
Cognitive Test1 - Visual Analog Scale
Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. Fifteen minutes after terminating anesthesia each subject will be asked to complete a series of psychomotor tests, if they are able. Otherwise the testing started at 30 minutes. The tests will be repeated every 15 minutes. The first test, a visual analog scale (VAS) test consisted of two 100-mm lines, each labelled with of "feel good" or "feel bad" displayed on a computer screen. Test subjects will be asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test will be repeated every 15 minutes.
Measured: Up to 120 minutes after terminating anesthesia.
Cognitive Test2 - Sternberg Test of Memory
Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test will be applied at 15 minutes following anesthesia, if the subject is awake and then repeated every 15 minutes. In the Sternberg Test of Memory (STM) participants are asked to memorize a string of numbers. Afterwards, a computer will flash a series of random numbers on the screen and the participant is asked whether the number on the computer screen are part of the earlier string or not. In three rounds, participants are given a string of 2, then 4, then 6 numbers. The latency until the subject answers the question is also monitored.
Measured: Up to 120 minutes after terminating anesthesia.
Cognitive Test3 - Divided Attention Task
Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test is first applied at 15 minutes following anesthesia, if the subject is awake and then repeated every 15 minutes. In the Divided Attention Task (DAT), participants are asked to fly an airplane over the center of a winding road with a joystick and simultaneously press a button whenever targets randomly flash on the screen. The computer program tracks the root mean squared (RMS) deviation of the plane from the center of the road and the latency for pressing the trigger when the target appears.
Measured: Up to 120 minutes after terminating anesthesia.
Bispectral Index
A bispectral index (BIS) measurement system is employed to measure depth of anesthesia. In particular, we wish to determine whether BIS exhibits more rapid recovery after caffeine compared to control.
Measured: Up to 120 minutes after terminating anesthesia.
Mean Arterial Blood Pressure
This measurement is made in order to determine whether caffeine alters blood pressure in a deleterious manner.
Measured: Up to 120 minutes after terminating anesthesia.
Heart Rate
This measurement is made in order to determine whether caffeine alters heart rate in a deleterious manner.
Measured: Up to 120 minutes after terminating anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start2 Jan 2018
- Primary completion31 Dec 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360903
- Sponsor's protocol ID
- IRB17-1174
- Other IDs
- 1R01GM116119
- Status last verified
- Oct 2019
- First submitted
- 21 Nov 2017
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Study to Determine if Caffeine Citrate Accelerates Emergence From Anesthesia
- ClinicalTrials.gov ID
- NCT03360903
- Acronym / sponsor ID
- IRB17-1174
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Posted 18 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present clinicians have no way to reverse anesthesia. Patients wake when their bodies clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and other cognitive problems after waking from anesthesia. In studies on animals, the investigators observed that caffeine caused rats to wake much more rapidly from propofol anesthesia. This was true for all the animals tested. The investigators would like to see if this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse the cognitive deficits associated with anesthesia, after waking?
The propose investigators carrying out a modest trial with 8 test subjects. Each volunteer will be anesthetized twice. Each volunteer will be anesthetized one time and receive an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer will receive an infusion of a relatively low dose of caffeine. The order of saline versus caffeine will be randomized and the study will be done in a double blind manner. We will determine whether emergence from propofol anesthesia will be significantly accelerated by the caffeine infusion. And whether any adverse events are observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo then Caffeine | Experimental | Drug: Placebo, Drug: CaffeineAnesthetized volunteers will be allowed to wake after injection of saline (placebo control) followed by a washout period and then anesthetized again and allowed to wake after injection of caffeine (15 mg/ kg). |
| Caffeine then Placebo | Experimental | Drug: Placebo, Drug: CaffeineAnesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg) followed by a washout period and then anesthetized again and allowed to wake after injection of saline (placebo control). |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age 25-40.
- Male.
- Normal healthy subject without systematic diseases or conditions.
- Metabolic Equivalents of Functional Capacity >= 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
Key exclusion criteria (15 listed)
- Age <25 or >40.
- Female.
- ASA physical status > 1 (normal healthy subject without 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
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 |
|---|---|---|
| PlaceboAnesthetized volunteers will be allowed to wake after injection of saline (placebo control). Other Names: * Saline | Drug | Caffeine then Placebo, Placebo then Caffeine |
| CaffeineAnesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). Other Names: * Caffeine citrate | Drug | Caffeine then Placebo, Placebo then Caffeine |
Primary outcome
Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes.
Time frame: 15 minutes
The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject opening their eyes will be measured. The time to "emerge" from anesthesia will be defined as the time between terminating the anesthesia and the test subject opening their eyes.
6 secondary outcomes
Cognitive Test1 - Visual Analog Scale
Time frame: Up to 120 minutes after terminating anesthesia.
Cognitive Test2 - Sternberg Test of Memory
Time frame: Up to 120 minutes after terminating anesthesia.
Cognitive Test3 - Divided Attention Task
Time frame: Up to 120 minutes after terminating anesthesia.
Bispectral Index
Time frame: Up to 120 minutes after terminating anesthesia.
Mean Arterial Blood Pressure
Time frame: Up to 120 minutes after terminating anesthesia.
Heart Rate
Time frame: Up to 120 minutes after terminating anesthesia.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 4 study testing Caffeine in people with 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 15 inclusion and 15 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 Nov 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. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes. (time frame: 15 minutes). 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 18 Nov 2019; AzTrials last refreshed its copy on 28 Oct 2026.