NCT03213912

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

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 29, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1.8 years

First QC Date

July 3, 2017

Last Update Submit

June 24, 2019

Conditions

Deep Brain Stimulation

Keywords

effective concentration

Outcome Measures

Primary Outcomes (1)

  • Cet of propofol

    concentration of propofol used during microelectrode recording

    Intraoperative

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Aged 20-85
  • Clinical diagnosis of Parkinson's disease
  • Scheduled for deep brain stimulation surgery under general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Study Officials

  • WT Change, M.D., Ph.D.

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 11, 2017

Study Start

January 29, 2016

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

June 25, 2019

Record last verified: 2019-06

Locations

TW(1)