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MAC Bipsectral Index Below 50 for Chronic Opioid User

The Effect of Chronic Opioid Use on Minimum Alveolar Concentration of Sevoflurane for Maintaining Bispectral(BIS) Index Below 50 ; Prospective, Blind Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02582437
Enrollment
20
Registered
2015-10-21
Start date
2015-06-30
Completion date
2016-06-30
Last updated
2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Minimum Alveolar Concentration

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)

Interventions

OTHERHistory for opioid use

Sponsors

National Cancer Center, Korea
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
41 Years to 69 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026