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MAC Bipsectral Index Below 50 for Chronic Opioid User

N

National Cancer Center (NCC)

Status

Unknown

Conditions

Anesthesia

Treatments

Other: History for opioid use

Study type

Interventional

Funder types

Other

Identifiers

NCT02582437
NCC2015-0147

Details and patient eligibility

About

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.

Full 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)

Enrollment

20 estimated patients

Sex

All

Ages

41 to 69 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

Chronic Opioid User
Experimental group
Description:
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)
Treatment:
Other: History for opioid use
Opioid Naive patient
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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