AnesthesiaNCT02582437
MAC Bipsectral Index Below 50 for Chronic Opioid User
A study testing History for opioid use in people with Anesthesia, run by National Cancer Center, Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 41 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- History for opioid use
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients(ASA class I-III) who receive elective surgery
- signed in informed consent to participate in this trial voluntarily.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, National Cancer Center
Goyang-si, Gyeonggi-do 10408, 156-031
Tak Kyu Oh, M.D., +82-10-2602-5950, 63019@ncc.re.kr
Dae Hyun Kim, M.D. Ph.D, +82-031-920-1699, dhkim@ncc.re.kr
About this study
Official title: The Effect of Chronic Opioid Use on Minimum Alveolar Concentration of Sevoflurane for Maintaining Bispectral(BIS) Index Below 50 ; Prospective, Blind Study
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.
Read the detailed description
- Patients selection in elective surgery which need general anesthesia.
- MAC BIS50 data was collected in each patients (by blinded investigator)
- The data collection will be continued for enough sample size for using Dixon Up Down Method Analysis
- After Data collection, MAC BIS below 50 will be analyzed in both groups ( Chronic opioid users versus opioid naive patients)
- Conditions
- Anesthesia
- Being tested
- History for opioid use
- Keywords
- Minimum Alveolar Concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
History for opioid useOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes after pre-set of the concentration of sevoflurane
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oh Tak Kyu, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582437
- Sponsor's protocol ID
- NCC2015-0147
- Status last verified
- Oct 2015
- First submitted
- 16 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19168857Oh 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.
PubMed 28614132
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronic Opioid Use on Minimum Alveolar Concentration of Sevoflurane for Maintaining Bispectral(BIS) Index Below 50 ; Prospective, Blind Study
- ClinicalTrials.gov ID
- NCT02582437
- Acronym / sponsor ID
- NCC2015-0147
- Conditions
- Anesthesia
- Keywords
- Minimum Alveolar Concentration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Patients selection in elective surgery which need general anesthesia.
- MAC BIS50 data was collected in each patients (by blinded investigator)
- The data collection will be continued for enough sample size for using Dixon Up Down Method Analysis
- After Data collection, MAC BIS below 50 will be analyzed in both groups ( Chronic opioid users versus opioid naive patients)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Opioid User | Experimental | Other: History for opioid useThe 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) |
| 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. |
Who may qualify
- Ages
- 41 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients(ASA class I-III) who receive elective surgery
- signed in informed consent to participate in this trial voluntarily.
Key exclusion criteria (7 listed)
- History of Monoamine Oxidase (MAO) inhibitor use
- Chronic alcoholics
- Acute alcohol abuser
- Contraindication for inhalation agent use (Sevoflurane)
- BMI >30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| History for opioid use | Other | Chronic Opioid User |
Primary outcome
Minimum Alveolar Concentration below BIS 50 in Sevoflurane; percentage (eg: 1.2%)
Time frame: 15 minutes after pre-set of the concentration of sevoflurane
Dixon's up down method is applied in this study. So pre-set concentration of sevoflurane will be used in each group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Background: PubMed 19168857Matsuura 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.
- Derived from this study: PubMed 28614132Oh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Anesthesiology and Pain Medicine, National Cancer Center
Goyang-si, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing History for opioid use in people with Anesthesia, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Alveolar Concentration below BIS 50 in Sevoflurane; percentage (eg: 1.2%) (time frame: 15 minutes after pre-set of the concentration of sevoflurane). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02582437, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.