MAC Bipsectral Index Below 50 for Chronic Opioid User

NCT02582437 | Unknown DMC

• 1 other identifier: NCC2015-0147
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Minimum Alveolar Concentration

Outcome Measures

Primary Outcomes (1)

• Minimum Alveolar Concentration below BIS 50 in Sevoflurane; percentage (eg: 1.2%)

  Dixon's up down method is applied in this study. So pre-set concentration of sevoflurane will be used in each group.

  15 minutes after pre-set of the concentration of sevoflurane

Study Arms (2)

Chronic Opioid User

EXPERIMENTAL

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)

Other: History for opioid use

Opioid Naive patient

NO INTERVENTION

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.

Interventions

History for opioid use OTHER

Chronic Opioid User

Eligibility Criteria

• Age: 41 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, National Cancer Center

Goyang-si, Gyeonggi-do 10408, 156-031, South Korea

RECRUITING

Related Publications (2)

• Matsuura T, Oda Y, Tanaka K, Mori T, Nishikawa K, Asada A. Advance of age decreases the minimum alveolar concentrations of isoflurane and sevoflurane for maintaining bispectral index below 50. Br J Anaesth. 2009 Mar;102(3):331-5. doi: 10.1093/bja/aen382. Epub 2009 Jan 24.

  PMID: 19168857 BACKGROUND

• Oh TK, Eom W, Yim J, Kim N, Kwon K, Kim SE, Kim DH. The Effect of Chronic Opioid Use on End-Tidal Concentration of Sevoflurane Necessary to Maintain a Bispectral Index Below 50: A Prospective, Single-Blind Study. Anesth Analg. 2017 Jul;125(1):156-161. doi: 10.1213/ANE.0000000000001791.

  PMID: 28614132 DERIVED

MeSH Terms

Interventions

Health Records, Personal

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 21, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

KR (1)