EC50 of Anesthetics During Microelectric Recording

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

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.

Study Overview

• Status: Completed
• Conditions: Deep Brain Stimulation

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 Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cet of propofol	concentration of propofol used during microelectrode recording	Intraoperative

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: WT Change, M.D., Ph.D., Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2016
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 9, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: effective concentration
• Other Study ID Numbers: 2015-12-004B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No