Parkinson's DiseaseNCT01992692
Remifentanil Requirement in Patients Receiving Surgical Treatment of 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 one the main neurodegenerative disease with an incidence of about 3% in patients older than 65 years. Anesthesia in PD patients has been focused by several studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian medication or Parkinsonian symptoms. 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: Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement, as well as non-Parkinsonian patients undergoing intracranial surgery
Who may be able to join
- Adult Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement
- Adult non-Parkinsonian patients undergoing intracranial surgery
Who cannot join
- ASA score higher than Class II
- predicted difficult airway
- alcohol or drug abuser
- informed consent was not provided
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 one the main neurodegenerative disease with an incidence of about 3% in patients older than 65 years. Anesthesia in PD patients has been focused by several studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian medication or Parkinsonian symptoms. However, our previous experience showed that the patients undergoing pulse generator placement were more prone to be involved in delayed emergence in the recovery room, which had been not reported yet. We speculated that PD patients might be a special population with abnormal pharmacodynamic characters of anesthetics, though no related evidence could be found to support this hypothesis. Therefore, in this project we investigated whether remifentanl requirement to inhibit patients' response to trachea intubation and skin insertion in PD patients undergoing DBS and pulse generator placement was different from non-PD patients undergoing intracranial surgery for reasons other than PD.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, remifentanil, deep brain stimulator, cardiovascular response
- 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 | Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement | |
| non-PD group | Non-Parkinsonian patients undergoing intracranial surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations required to inhibit response to trachea intubation and skin incision
Measured: Anesthesia induction to 5min after skin incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992692
- Sponsor's protocol ID
- Parkinson-remifentanil
- Status last verified
- Jun 2013
- First submitted
- 19 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang JF, Xu XP, Yu XY, Li JB, Wu X, Chen JC, Hu XW, Deng XM. Remifentanil Requirement for Inhibiting Responses to Tracheal Intubation and Skin Incision Is Reduced in Patients With Parkinson's Disease Undergoing Deep Brain Stimulator Implantation. J Neurosurg Anesthesiol. 2016 Oct;28(4):303-8. doi: 10.1097/ANA.0000000000000229.
PubMed 26368663
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Requirement in Patients Receiving Surgical Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01992692
- Acronym / sponsor ID
- Parkinson-remifentanil
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, remifentanil, deep brain stimulator, cardiovascular response
- 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
- 25 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 one the main neurodegenerative disease with an incidence of about 3% in patients older than 65 years. Anesthesia in PD patients has been focused by several studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian medication or Parkinsonian symptoms. However, our previous experience showed that the patients undergoing pulse generator placement were more prone to be involved in delayed emergence in the recovery room, which had been not reported yet. We speculated that PD patients might be a special population with abnormal pharmacodynamic characters of anesthetics, though no related evidence could be found to support this hypothesis. Therefore, in this project we investigated whether remifentanl requirement to inhibit patients' response to trachea intubation and skin insertion in PD patients undergoing DBS and pulse generator placement was different from non-PD patients undergoing intracranial surgery for reasons other than PD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD group | – | –Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement |
| non-PD group | – | –Non-Parkinsonian patients undergoing intracranial surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement, as well as non-Parkinsonian patients undergoing intracranial surgery
Key inclusion criteria (2 listed)
- Adult Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement
- Adult non-Parkinsonian patients undergoing intracranial surgery
Key exclusion criteria (4 listed)
- ASA score higher than Class II
- predicted difficult airway
- alcohol or drug abuser
- informed consent was not provided
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
Concentrations required to inhibit response to trachea intubation and skin incision
Time frame: Anesthesia induction to 5min after skin incision
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 Nov 2013.
- Derived from this study: PubMed 26368663Wang JF, Xu XP, Yu XY, Li JB, Wu X, Chen JC, Hu XW, Deng XM. Remifentanil Requirement for Inhibiting Responses to Tracheal Intubation and Skin Incision Is Reduced in Patients With Parkinson's Disease Undergoing Deep Brain Stimulator Implantation. J Neurosurg Anesthesiol. 2016 Oct;28(4):303-8. doi: 10.1097/ANA.0000000000000229.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 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?
Concentrations required to inhibit response to trachea intubation and skin incision (time frame: Anesthesia induction to 5min after skin incision). 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 NCT01992692, 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 25 Nov 2013.