AnesthesiaPhase 1/2NCT03610282
EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation
A Phase 1/2 study testing IV Methylphenidate and Propofol in people with Anesthesia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are performing this research study to find out if intravenous (IV) methylphenidate (commonly known as Ritalin) can help people recover faster from propofol sedation. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- IV Methylphenidate 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
- 1 siteUnited States
- Study dates
- Nov 2019to Nov 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 to 45
- Normal body weight and habitus, BMI ≤ 30
- Non-smoker
- No history of taking stimulants
- American Society of Anesthesiologists (ASA) physical status classification P1
Who cannot join
- Chronic health conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation
The investigators are performing this research study to find out if intravenous (IV) methylphenidate (commonly known as Ritalin) can help people recover faster from propofol sedation. The investigators also want to know how IV methylphenidate acts in the brain and whether IV methylphenidate is safe to take with an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness) without causing too many side effects. The brain's electrical activity will be studied and recorded using a machine called an electroencephalogram (EEG).
Read the detailed description
During this research study, participants will receive propofol, and propofol and IV methylphenidate together, at a high enough dose to achieve unconsciousness (make study participants "fall asleep"). During one visit participants will receive propofol and a saline placebo; during another visit participants will be given both propofol and IV methylphenidate together. The investigators will record EEG the entire time, The investigators will also ask some questions related to cognitive function.
- Conditions
- Anesthesia
- Being tested
- IV Methylphenidate, Propofol
- Keywords
- Propofol, Methylphenidate, Ritalin, Anesthetics, Anesthetics, Intravenous, Molecular Mechanisms of Pharmacological Action, Anesthetics, General, Neurotransmitter Agents, Physiological Effects of Drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV MethylphenidateDrug
Also called Ritalin
Subjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits.
PropofolDrug
Subjects will received propofol for up to 100 minutes.
| Study group | Role | What they receive |
|---|---|---|
| EEG Dynamics | Experimental | EEG data will be collected on patients receiving propofol and IV methylphenidate together. Receives: Drug: IV Methylphenidate; Drug: Propofol |
| Propofol EEG Dynamics | Placebo comparator | EEG data will be collected on patients receiving propofol and a saline placebo. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in multitaper spectral estimates of EEG power during a continuous infusion of propofol.
Change from baseline in multitaper spectral estimates of EEG power associated with the administration of IV methylphenidate.
Measured: Up to 100 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startNov 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: We have decided to withdraw the study prior to enrollment of the first participant in order to pursue other research studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- 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
- Investigators
- Ken Solt, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610282
- Sponsor's protocol ID
- 2018P001421
- Status last verified
- Feb 2020
- First submitted
- 26 Jul 2018
- Last updated
- 21 Feb 2020
- 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 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation
- ClinicalTrials.gov ID
- NCT03610282
- Acronym / sponsor ID
- 2018P001421
- Conditions
- Anesthesia
- Keywords
- Propofol, Methylphenidate, Ritalin, Anesthetics, Anesthetics, Intravenous, Molecular Mechanisms of Pharmacological Action, Anesthetics, General, Neurotransmitter Agents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We have decided to withdraw the study prior to enrollment of the first participant in order to pursue other research studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 1 Aug 2018 (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.
The investigators are performing this research study to find out if intravenous (IV) methylphenidate (commonly known as Ritalin) can help people recover faster from propofol sedation. The investigators also want to know how IV methylphenidate acts in the brain and whether IV methylphenidate is safe to take with an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness) without causing too many side effects. The brain's electrical activity will be studied and recorded using a machine called an electroencephalogram (EEG).
Detailed description
During this research study, participants will receive propofol, and propofol and IV methylphenidate together, at a high enough dose to achieve unconsciousness (make study participants "fall asleep"). During one visit participants will receive propofol and a saline placebo; during another visit participants will be given both propofol and IV methylphenidate together. The investigators will record EEG the entire time, The investigators will also ask some questions related to cognitive function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG Dynamics | Experimental | Drug: IV Methylphenidate, Drug: PropofolEEG data will be collected on patients receiving propofol and IV methylphenidate together. |
| Propofol EEG Dynamics | Placebo comparator | Drug: PropofolEEG data will be collected on patients receiving propofol and a saline placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 18 to 45
- Normal body weight and habitus, BMI ≤ 30
- Non-smoker
- No history of taking stimulants
- American Society of Anesthesiologists (ASA) physical status classification P1
Key exclusion criteria (1 listed)
- Chronic health conditions
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 MethylphenidateAlso: RitalinSubjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits. | Drug | EEG Dynamics |
| PropofolSubjects will received propofol for up to 100 minutes. | Drug | EEG Dynamics, Propofol EEG Dynamics |
Primary outcome
Change in multitaper spectral estimates of EEG power during a continuous infusion of propofol.
Time frame: Up to 100 minutes
Change from baseline in multitaper spectral estimates of EEG power associated with the administration of IV methylphenidate.
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 21 Feb 2020.
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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.
Ken Solt, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IV Methylphenidate and Propofol in people with Anesthesia, run by Massachusetts General Hospital 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 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 21 Feb 2020. 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 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?
Change in multitaper spectral estimates of EEG power during a continuous infusion of propofol. (time frame: Up to 100 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 21 Feb 2020.