Active Emergence From General AnesthesiaPhase 1/2NCT02429076
EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia
A Phase 1/2 study testing IV methylphenidate, Sevoflurane and Propofol in people with Active Emergence From General Anesthesia, run by Massachusetts General Hospital.
Trial summary
The aim of this study is to test the hypothesis that methylphenidate actively induces emergence from propofol and sevoflurane general anesthesia in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Active Emergence From General Anesthesia
- What is being tested?
- IV methylphenidate, Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Dec 2019
- Phase
- Phase 1/2
- 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 18 to 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-36 years
- ASA classification 1 or 2
- Normal body weight, BMI ≤ 30
- Non-smoker
- Right handed
- No history of taking stimulants
Who cannot join
- In general, patients will be excluded from the study if the state of their chronic health problems gives them an ASA physical status classification of 3 or beyond.
About this study
Official title: Electroencephalogram Studies of Intravenous Methylphenidate-Induced Emergence From General Anesthesia
The aim of this study is to test the hypothesis that methylphenidate actively induces emergence from propofol and sevoflurane general anesthesia in healthy volunteers.
Read the detailed description
Basic science and clinical data suggest that activation of one or more of the brain's arousal pathways is a highly plausible way to induce active emergence from general anesthesia. The investigators have compelling experimental data demonstrating that methylphenidate is highly effective in actively inducing emergence from isoflurane and propofol general anesthesia in rodents. The available literature suggests that IV methylphenidate would be safe to administer to patients recovering from general anesthesia, and that in addition to promoting arousal, it would enhance breathing. Both of these effects would be highly desirable in patients recovering from general anesthesia.
- Conditions
- Active Emergence From General Anesthesia
- Being tested
- IV methylphenidate, Placebo, Sevoflurane, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV methylphenidateDrug
IV methylphenidate will be administered to induce emergence from general anesthesia.
PlaceboDrug
normal saline
SevofluraneDrug
Inhaled anesthetic
PropofolDrug
IV anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Subjects in this arm will receive propofol general anesthesia Receives: Drug: IV methylphenidate; Drug: Placebo; Drug: Propofol |
| Sevoflurane | Experimental | Subjects in this arm will receive sevoflurane general anesthesia Receives: Drug: IV methylphenidate; Drug: Placebo; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to methlyphenidate administration
The number of minutes from the administration of methylphenidate until subjects respond to verbal commands
Measured: minutes to response, expected average is less than 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJun 2017 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: We are not going to complete this study with healthy volunteers at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Emergence From General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken Solt, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429076
- Sponsor's protocol ID
- 2015P000566
- Status last verified
- Aug 2017
- First submitted
- 8 Apr 2015
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalogram Studies of Intravenous Methylphenidate-Induced Emergence From General Anesthesia
- ClinicalTrials.gov ID
- NCT02429076
- Acronym / sponsor ID
- 2015P000566
- Conditions
- Active Emergence From General Anesthesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We are not going to complete this study with healthy volunteers at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Apr 2015 (estimated)
- 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.
The aim of this study is to test the hypothesis that methylphenidate actively induces emergence from propofol and sevoflurane general anesthesia in healthy volunteers.
Detailed description
Basic science and clinical data suggest that activation of one or more of the brain's arousal pathways is a highly plausible way to induce active emergence from general anesthesia. The investigators have compelling experimental data demonstrating that methylphenidate is highly effective in actively inducing emergence from isoflurane and propofol general anesthesia in rodents. The available literature suggests that IV methylphenidate would be safe to administer to patients recovering from general anesthesia, and that in addition to promoting arousal, it would enhance breathing. Both of these effects would be highly desirable in patients recovering from general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: IV methylphenidate, Drug: Placebo, Drug: PropofolSubjects in this arm will receive propofol general anesthesia |
| Sevoflurane | Experimental | Drug: IV methylphenidate, Drug: Placebo, Drug: SevofluraneSubjects in this arm will receive sevoflurane general anesthesia |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-36 years
- ASA classification 1 or 2
- Normal body weight, BMI ≤ 30
- Non-smoker
- Right handed
Key exclusion criteria (1 listed)
- In general, patients will be excluded from the study if the state of their chronic health problems gives them an ASA physical status classification of 3 or beyond.
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 |
|---|---|---|
| IV methylphenidateIV methylphenidate will be administered to induce emergence from general anesthesia. | Drug | Propofol, Sevoflurane |
| Placebonormal saline | Drug | Propofol, Sevoflurane |
| SevofluraneInhaled anesthetic | Drug | Sevoflurane |
| PropofolIV anesthetic | Drug | Propofol |
Primary outcome
Response to methlyphenidate administration
Time frame: minutes to response, expected average is less than 10 minutes
The number of minutes from the administration of methylphenidate until subjects respond to verbal commands
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 2 Aug 2017.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IV methylphenidate, Sevoflurane and Propofol in people with Active Emergence From General Anesthesia, run by Massachusetts General Hospital.
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 6 inclusion and 1 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 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response to methlyphenidate administration (time frame: minutes to response, expected average is less than 10 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 2 Aug 2017.