NCT01998204

Brief 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. Abnormal pharmacodynamics might be present among these patients, which had never been investigated.

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

Click on a node to explore related trials.

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
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

1.4 years

First QC Date

November 19, 2013

Last Update Submit

November 23, 2013

Conditions

Keywords

Parkinson's diseasepropofoldeep brain stimulator

Outcome Measures

Primary Outcomes (1)

  • Consciousness status

    Consciousness status is evaluated by the observer's assessment of alertness and sedation score (OAA/S).

    Participants will be monitored during the period of propofol infusion, an expected average of less than 10 min

Study Arms (2)

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

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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)

  • 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.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jia-feng Wang, M.D.

    Department of Anesthesiology, Changhai Hospital, Second Military Medical University

    PRINCIPAL INVESTIGATOR

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 28, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations