EC50 of Anesthetics During Microelectric Recording

NCT ID: NCT03213912

Last Updated: 2019-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-29

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Deep Brain Stimulation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Allergic history to dexmedetomidine and propofol
2. Clinical diagnosis of congestive heart failure
3. Clinical diagnosis of liver cirrhosis
4. Clinical diagnosis of third degree A-V block
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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vghtpe user

Principal Investigator, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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WT Change, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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2015-12-004B

Identifier Type: -

Identifier Source: org_study_id

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