Parkinson's DiseaseNCT01998204
Requirement of Propofol for Induction of Unconsciousness in Patients With Parkinson's Disease
An observational study of Parkinson's Disease, run by Changhai Hospital at 1 site in China.
Trial summary
Parkinson's disease (PD) is the second most prevalent neurodegenerative disease. The investigators clinical experience showed a trend of delayed emergence among patients undergoing deep brain stimulator (DBS) implantation and pulse generator placement under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jun 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study recruits patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia and non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia
Who may be able to join
- Patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia
- non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia
Who cannot join
- ASA score higher than Class III
- predicted difficult airway
- hearing impairment
- inability to corporate with instruction
- alcohol or drug abuser
- patients refusing to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Changhai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Parkinson's disease (PD) is the second most prevalent neurodegenerative disease. The investigators clinical experience showed a trend of delayed emergence among patients undergoing deep brain stimulator (DBS) implantation and pulse generator placement under general anesthesia. Abnormal pharmacodynamics might be present among these patients, which had never been investigated.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, propofol, deep brain stimulator
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PD group | Patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement | |
| non-PD group | Patients without Parkinson's disease undergoing intracranial surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consciousness status
Consciousness status is evaluated by the observer's assessment of alertness and sedation score (OAA/S).
Measured: Participants will be monitored during the period of propofol infusion, an expected average of less than 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-feng Wang, Changhai Hospital
- Investigators
- Jia-feng Wang, M.D., Principal investigator, Department of Anesthesiology, Changhai Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998204
- Sponsor's protocol ID
- Parkinson-propofol
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu XP, Yu XY, Wu X, Hu XW, Chen JC, Li JB, Wang JF, Deng XM. Propofol requirement for induction of unconsciousness is reduced in patients with Parkinson's disease: a case control study. Biomed Res Int. 2015;2015:953729. doi: 10.1155/2015/953729. Epub 2015 Oct 1.
PubMed 26495319
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Requirement of Propofol for Induction of Unconsciousness in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01998204
- Acronym / sponsor ID
- Parkinson-propofol
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, propofol, deep brain stimulator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Nov 2013 (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.
Parkinson's disease (PD) is the second most prevalent neurodegenerative disease. The investigators clinical experience showed a trend of delayed emergence among patients undergoing deep brain stimulator (DBS) implantation and pulse generator placement under general anesthesia. Abnormal pharmacodynamics might be present among these patients, which had never been investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD group | – | –Patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement |
| non-PD group | – | –Patients without Parkinson's disease undergoing intracranial surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study recruits patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia and non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia
Key inclusion criteria (2 listed)
- Patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia
- non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia
Key exclusion criteria (6 listed)
- ASA score higher than Class III
- predicted difficult airway
- hearing impairment
- inability to corporate with instruction
- alcohol or drug abuser
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
Consciousness status
Time frame: Participants will be monitored during the period of propofol infusion, an expected average of less than 10 min
Consciousness status is evaluated by the observer's assessment of alertness and sedation score (OAA/S).
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 28 Nov 2013.
- Derived from this study: PubMed 26495319Xu XP, Yu XY, Wu X, Hu XW, Chen JC, Li JB, Wang JF, Deng XM. Propofol requirement for induction of unconsciousness is reduced in patients with Parkinson's disease: a case control study. Biomed Res Int. 2015;2015:953729. doi: 10.1155/2015/953729. Epub 2015 Oct 1.
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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.
Jia-feng Wang, M.D. principal investigator
Department of Anesthesiology, Changhai Hospital, Second Military Medical University
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 Parkinson's Disease, run by Changhai Hospital at 1 site in China.
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 2 inclusion and 6 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 28 Nov 2013. 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 China. 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?
Consciousness status (time frame: Participants will be monitored during the period of propofol infusion, an expected average of less than 10 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01998204, which also lists 1 linked publication.
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 28 Nov 2013.