MAC Bipsectral Index Below 50 for Chronic Opioid User

Not Applicable

• Conditions: Anesthesia
• Interventions: Other: History for opioid use

• Registration Number: NCT02582437
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

The purpose of this study is to find difference in Minimum Alveolar Concentration(MAC) for maintaining Bispectral Index (BIS) below 50 between chronic opioid users and opioid naive patients.

Detailed Description

1. Patients selection in elective surgery which need general anesthesia.

2. MAC BIS50 data was collected in each patients (by blinded investigator)

3. The data collection will be continued for enough sample size for using Dixon Up Down Method Analysis

4. After Data collection, MAC BIS below 50 will be analyzed in both groups ( Chronic opioid users versus opioid naive patients)

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-10
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-19
• Last Update Submitted: 2015-10-19
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-21
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• The patients(ASA class I-III) who receive elective surgery
• signed in informed consent to participate in this trial voluntarily.

Exclusion Criteria

• History of Monoamine Oxidase (MAO) inhibitor use
• Chronic alcoholics
• Acute alcohol abuser
• Contraindication for inhalation agent use (Sevoflurane)
• BMI >30
• History of medication use, which affect in the minimum concentration of sevoflurane;(barbiturates, chlorpromazine, diazepam, hydroxyzine, verapamil, marijuana)
• Craniotomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic Opioid User	History for opioid use	The patients (ASA class I-III) who receive elective surgery s aging between 41 and 69 and signed in informed consent to participate in this trial voluntarily. The Patients who use opioid medication daily and regularly immediately before the day of surgery for more than four weeks. The minimum criteria for opioid dose in the intervention goup is oral morphine 20mg per day: Morphine Equivalent Daily Dose(MEDD)

Primary Outcome Measures

Name	Time	Method
Minimum Alveolar Concentration below BIS 50 in Sevoflurane; percentage (eg: 1.2%)	15 minutes after pre-set of the concentration of sevoflurane	Dixon's up down method is applied in this study. So pre-set concentration of sevoflurane will be used in each group.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do 10408, Korea, Republic of