Deep Brain StimulationNCT03213912
EC50 of Anesthetics During Microelectric Recording
An observational study of Deep Brain Stimulation, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The investigators determine the half maximum effective concentration (EC50) of the Cet value of propofol in target-controlled infusion (TCI) when co-administered with dexmedetomidine for the maintenance of general anesthesia during microelectrode recording in the deep brain surgery in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Deep Brain Stimulation
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jan 2016to 31 Oct 2017
- Phase
- Observational
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, aged 20-85, with clinical diagnosis of Parkinson's disease, who are undergoing deep brain stimulation for which gnenral anesthesia with endotracheal intubation is required.
Who may be able to join
- Aged 20-85
- Clinical diagnosis of Parkinson's disease
- Scheduled for deep brain stimulation surgery under general anesthesia
Who cannot join
- Allergic history to dexmedetomidine and propofol
- Clinical diagnosis of congestive heart failure
- Clinical diagnosis of liver cirrhosis
- Clinical diagnosis of third degree A-V block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of EC50 of Anesthetics During Microelectric Recording in Patients Receiving Deep Brain Stimulation Under Anesthesia
The investigators determine the half maximum effective concentration (EC50) of the Cet value of propofol in target-controlled infusion (TCI) when co-administered with dexmedetomidine for the maintenance of general anesthesia during microelectrode recording in the deep brain surgery in patients with Parkinson's disease.
Read the detailed description
General anesthesia is sometimes required for DBS (deep brain stimulation) surgery in those with excessive fear, anxiety, reduced cooperation, or severe movements due to ' off drug' state. Dexmedetomidine and propofol are both used individually in the sedation for DBS surgery, and were reported to affect the MER (microelectrode recording) to some extent, especially in the higher zone of the dose range. In this study, the investigators plan to use the combination of dexmedetomidine and propofol for the maintenance of general anesthesia in patients with Parkinson's disease. In this study, dexmedetomidine is given with a loading dose of 0.5 mcg/Kg, and continuous infusion with the dose of 0.4 mcg/Kg/hr. Propofol is given within 0.8~1.8 mcg/Kg during the MER recording (based on institutional guideline). MER recording will be observed and correlated wtih the dose of propofol. The Dixon "up-and-down" sequential allocation method was used to determine the EC50 of the value of Cet of propofol. The study aims to determine the dose that is adequate for maintaining general anesthesia with endotracheal intubation and least interference with the MER recording.
- Conditions
- Deep Brain Stimulation
- Keywords
- effective concentration
What is being measured
The primary outcome is the main question the study is designed to answer.
Cet of propofol
concentration of propofol used during microelectrode recording
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start29 Jan 2016
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- WT Change, M.D., Ph.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213912
- Sponsor's protocol ID
- 2015-12-004B
- Status last verified
- Jun 2019
- First submitted
- 3 Jul 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of EC50 of Anesthetics During Microelectric Recording in Patients Receiving Deep Brain Stimulation Under Anesthesia
- ClinicalTrials.gov ID
- NCT03213912
- Acronym / sponsor ID
- 2015-12-004B
- Conditions
- Deep Brain Stimulation
- Keywords
- effective concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 29 Jan 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 11 Jul 2017 (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 determine the half maximum effective concentration (EC50) of the Cet value of propofol in target-controlled infusion (TCI) when co-administered with dexmedetomidine for the maintenance of general anesthesia during microelectrode recording in the deep brain surgery in patients with Parkinson's disease.
Detailed description
General anesthesia is sometimes required for DBS (deep brain stimulation) surgery in those with excessive fear, anxiety, reduced cooperation, or severe movements due to ' off drug' state. Dexmedetomidine and propofol are both used individually in the sedation for DBS surgery, and were reported to affect the MER (microelectrode recording) to some extent, especially in the higher zone of the dose range. In this study, the investigators plan to use the combination of dexmedetomidine and propofol for the maintenance of general anesthesia in patients with Parkinson's disease. In this study, dexmedetomidine is given with a loading dose of 0.5 mcg/Kg, and continuous infusion with the dose of 0.4 mcg/Kg/hr. Propofol is given within 0.8~1.8 mcg/Kg during the MER recording (based on institutional guideline). MER recording will be observed and correlated wtih the dose of propofol. The Dixon "up-and-down" sequential allocation method was used to determine the EC50 of the value of Cet of propofol. The study aims to determine the dose that is adequate for maintaining general anesthesia with endotracheal intubation and least interference with the MER recording.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, aged 20-85, with clinical diagnosis of Parkinson's disease, who are undergoing deep brain stimulation for which gnenral anesthesia with endotracheal intubation is required.
Key inclusion criteria (3 listed)
- Aged 20-85
- Clinical diagnosis of Parkinson's disease
- Scheduled for deep brain stimulation surgery under general anesthesia
Key exclusion criteria (4 listed)
- Allergic history to dexmedetomidine and propofol
- Clinical diagnosis of congestive heart failure
- Clinical diagnosis of liver cirrhosis
- Clinical diagnosis of third degree A-V block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cet of propofol
Time frame: Intraoperative
concentration of propofol used during microelectrode recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Deep Brain Stimulation
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Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.3
Healthy Volunteers
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Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
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Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
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Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
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.
WT Change, M.D., Ph.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Brain Stimulation, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 3 inclusion and 4 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 25 Jun 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cet of propofol (time frame: Intraoperative). 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 25 Jun 2019.