MAC Bipsectral Index Below 50 for Chronic Opioid User

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Anesthesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Chronic Opioid User

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)

Group Type EXPERIMENTAL

History for opioid use

Intervention Type OTHER

Opioid Naive patient

The patients (ASA class I-III) who receive elective surgery aging between 41 and 69 and signed in informed consent to participate in this trial voluntarily.

The patients who do not use opioid medications immediately before the day of surgery for four weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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History for opioid use

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

41 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes