NCT01992692

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

June 1, 2013

Enrollment Period

1.4 years

First QC Date

November 19, 2013

Last Update Submit

November 19, 2013

Conditions

Keywords

Parkinson's diseaseremifentanildeep brain stimulatorcardiovascular response

Outcome Measures

Primary Outcomes (1)

  • Concentrations required to inhibit response to trachea intubation and skin incision

    Anesthesia induction to 5min after skin incision

Study Arms (2)

PD group

Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement

non-PD group

Non-Parkinsonian patients undergoing intracranial surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement, as well as non-Parkinsonian patients undergoing intracranial surgery

You may qualify if:

  • Adult Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement
  • Adult non-Parkinsonian patients undergoing intracranial surgery

You may not qualify if:

  • ASA score higher than Class II
  • predicted difficult airway
  • alcohol or drug abuser
  • informed consent was not provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-06

Locations