EC50 of Anesthetics During Microelectric Recording

Deep Brain Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213912
• Other study ID #: 2015-12-004B
• Status: Completed
• Start date: January 29, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: June 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Brain Stimulation

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cet of propofol	concentration of propofol used during microelectrode recording	Intraoperative