AnesthesiaPhase 4NCT02567968
A Study to Determine if Caffeine Accelerates Emergence From 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
- Aug 2016to 1 May 2017
- 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 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 and mice to wake much more rapidly from 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 investigators carried out a modest trial with 8 test subjects. Each volunteer was anesthetized twice. Each volunteer was anesthetized one time and received an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer received an infusion of a relatively low dose of caffeine. The order of saline versus caffeine was randomized and the study was done in a double blind manner. We observed that emergence from anesthesia was significantly accelerated by the caffeine infusion. No adverse events were observed.
- Conditions
- Anesthesia
- Being tested
- Caffeine, Placebo Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Also called Caffeine citrate
Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). The time to wake will be measured.
Placebo ControlDrug
Also called Saline
Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). The time to wake will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Anesthetized volunteers will be allowed to wake after injection of either saline (placebo control) or caffeine (15 mg/ kg). The time to wake will be measured. Receives: Drug: Placebo Control |
| Caffeine | Active comparator | Anesthetized volunteers will be allowed to wake after injection of either saline (placebo control) or caffeine (15 mg/ kg). The time to wake will be measured. Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waking Time - Re-establishment of the Gag Reflex.
The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject starting to gag was measured. Anesthesia suppresses the gag reflex. Immediately after anesthetizing the test subject, a laryngeal mask airway (LMA) device was inserted into the test subject airway. After anesthesia was terminated and emergence from anesthesia was taking place, the gag reflex was re-established, and the LMA produced a "gag response" in all test subjects. This objective and unequivocal measurement constituted the "emergence" time for each subject. The "emergence" time was defined as the time between terminating the anesthesia and the test subject starting to gag.
Measured: followed from the end of anesthesia to gag reflex, up to 2 hours
Secondary outcomes (8)
Cognitive Test1 - Visual Analog Scale --- Feel Good
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 was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were 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 were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes.
Measured: Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.
Cognitive Test1 - Visual Analog Scale --- Feel Bad
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 was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were 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 were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes.
Measured: Test was given at 15, 30, 45, 60, 75, 90, 105 and 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 was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Sternberg Test of Memory (STM) participants were asked to memorize a string of numbers. Afterwards, a computer would flash a series of random numbers on the screen and the participant was asked whether the number on the computer screen was part of the earlier string or not. In three rounds, participants were given a string of 2, then 4, then 6 numbers. The latency until the subject answered the question was monitored and this is the data summarized here.
Measured: Test was given at 15, 30, 45, 60 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 was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Divided Attention Task (DAT), participants were asked to fly an airplane over the center of a winding road with a joystick and simultaneously press a button whenever targets randomly flashed on the screen. The computer program tracked 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 appeared.
Measured: Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.
Bispectral Index
A bispectral index (BIS) measurement system was employed to measure depth of anesthesia. Using electrodes attached to the forehead to measure EEG, BIS outputs a dimensionless number between 0 and 100 that is proportional to the brain concentration of anesthetic and is thereby proportional to an individual's level of consciousness (Greenwald S, Chiang HH, Devlin P, Smith C, Sigl J, Chamoun N: The Bispectral Index (Bis2.0) as a Hypnosis Measure. Anesthesiology 1994; 81: A477-a477). When the test subjects arrive, prior to anesthesia, their BIS values are in the range of 95 - 99. That corresponds to an awake and alert state. During anesthesia, most subjects are in the range of 20 - 40, corresponding to an anesthetized state. As the anesthetic wears off, the BIS values rise until they are back in the 95 - 99 range that they were prior to anesthesia. In particular, we wished to determine whether BIS exhibited more rapid recovery after caffeine infusion as compared to saline (control).
Measured: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.
Minute Ventilation
The volume of gas inhaled or exhaled from a person's lungs per minute. We wished to determine whether caffeine altered minute ventilation.
Measured: Continuous monitoring from time lma inserted until subject started to gag and it was removed, up to 2 hours post-anesthesia.
Mean Arterial Blood Pressure
This measurement was made in order to determine whether caffeine altered blood pressure in a deleterious manner.
Measured: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.
Heart Rate
This measurement was made in order to determine whether caffeine altered heart rate in a deleterious manner.
Measured: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startAug 2016
- Primary completion1 May 2017
- Study completion1 May 2017
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
- Double blind
- Who is masked
- 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
- Investigators
- Aaron Fox, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567968
- Sponsor's protocol ID
- IRB15-0897
- Other IDs
- 1R01GM116119-01
- Status last verified
- Jul 2018
- First submitted
- 30 Sep 2015
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. 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
- NCT02567968
- Acronym / sponsor ID
- IRB15-0897
- 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
- Aug 2016
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Posted 18 Jul 2018
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 and mice to wake much more rapidly from 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 investigators carried out a modest trial with 8 test subjects. Each volunteer was anesthetized twice. Each volunteer was anesthetized one time and received an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer received an infusion of a relatively low dose of caffeine. The order of saline versus caffeine was randomized and the study was done in a double blind manner. We observed that emergence from anesthesia was significantly accelerated by the caffeine infusion. No adverse events were observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo ControlAnesthetized volunteers will be allowed to wake after injection of either saline (placebo control) or caffeine (15 mg/ kg). The time to wake will be measured. |
| Caffeine | Active comparator | Drug: CaffeineAnesthetized volunteers will be allowed to wake after injection of either saline (placebo control) or caffeine (15 mg/ kg). The time to wake will be measured. |
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 |
|---|---|---|
| CaffeineAlso: Caffeine citrateAnesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). The time to wake will be measured. | Drug | Caffeine |
| Placebo ControlAlso: SalineAnesthetized volunteers will be allowed to wake after injection of saline (placebo control). The time to wake will be measured. | Drug | Placebo |
Primary outcome
Waking Time - Re-establishment of the Gag Reflex.
Time frame: followed from the end of anesthesia to gag reflex, up to 2 hours
The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject starting to gag was measured. Anesthesia suppresses the gag reflex. Immediately after anesthetizing the test subject, a laryngeal mask airway (LMA) device was inserted into the test subject airway. After anesthesia was terminated and emergence from anesthesia was taking place, the gag reflex was re-established, and the LMA produced a "gag response" in all test subjects. This objective and unequivocal measurement constituted the "emergence" time for each subject. The "emergence" time was defined as the time between terminating the anesthesia and the test subject starting to gag.
8 secondary outcomes
Cognitive Test1 - Visual Analog Scale --- Feel Good
Time frame: Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.
Cognitive Test1 - Visual Analog Scale --- Feel Bad
Time frame: Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.
Cognitive Test2 - Sternberg Test of Memory
Time frame: Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.
Cognitive Test3 - Divided Attention Task
Time frame: Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.
Bispectral Index
Time frame: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.
Minute Ventilation
Time frame: Continuous monitoring from time lma inserted until subject started to gag and it was removed, up to 2 hours post-anesthesia.
Mean Arterial Blood Pressure
Time frame: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.
Heart Rate
Time frame: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- 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.
Aaron Fox, PhD principal investigator
University of Chicago
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 16 Aug 2018. 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 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 Jul 2018). 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 - Re-establishment of the Gag Reflex. (time frame: followed from the end of anesthesia to gag reflex, up to 2 hours). 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 16 Aug 2018; AzTrials last refreshed its copy on 28 Oct 2026.