MAC Bipsectral Index Below 50 for Chronic Opioid User

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02582437
• Other study ID #: NCC2015-0147
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2015
• Last updated: October 19, 2015
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: National Cancer Center
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 41 Years to 69 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• History for opioid use

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, National Cancer Center	Goyang-si	Gyeonggi-do 10408

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No