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Clinical Trials/NCT03213912
NCT03213912
Completed
Not Applicable

Determination of EC50 of Anesthetics During Microelectric Recording in Patients Receiving Deep Brain Stimulation Under Anesthesia

Taipei Veterans General Hospital, Taiwan1 site in 1 country23 target enrollmentStarted: January 29, 2016Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
1
Primary Endpoint
Cet of propofol

Overview

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.

Detailed Description

General anesthesia is sometimes required for DBS (deep brain stimulation) surgery in those with excessive fear, anxiety, reduced cooperation, or severe movements due to ' off drug' state. Dexmedetomidine and propofol are both used individually in the sedation for DBS surgery, and were reported to affect the MER (microelectrode recording) to some extent, especially in the higher zone of the dose range. In this study, the investigators plan to use the combination of dexmedetomidine and propofol for the maintenance of general anesthesia in patients with Parkinson's disease. In this study, dexmedetomidine is given with a loading dose of 0.5 mcg/Kg, and continuous infusion with the dose of 0.4 mcg/Kg/hr. Propofol is given within 0.8~1.8 mcg/Kg during the MER recording (based on institutional guideline). MER recording will be observed and correlated wtih the dose of propofol. The Dixon "up-and-down" sequential allocation method was used to determine the EC50 of the value of Cet of propofol. The study aims to determine the dose that is adequate for maintaining general anesthesia with endotracheal intubation and least interference with the MER recording.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Cet of propofol

Time Frame: Intraoperative

concentration of propofol used during microelectrode recording

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

vghtpe user

Principal Investigator, Associate Professor

Taipei Veterans General Hospital, Taiwan

Study Sites (1)

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