Bispectral Index, Monitored Anesthesia CareBISMACNCT03410082
Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care
A study testing Titration under the guidance of BIS and Titration under the guidance of OAA/S in people with Bispectral Index, Monitored Anesthesia Care, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators will evaluate the effect of bispectral index-guided titration of sedation during ear surgery under monitored anesthesia care on participant's satisfaction with anesthesia, as well as side effects caused by the anesthetics. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Bispectral Index, Monitored Anesthesia Care
- What is being tested?
- Titration under the guidance of BIS and Titration under the guidance of OAA/S
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Aug 2017to 30 Mar 2019
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving ear surgery with ASA physical status 1 or 2
Who cannot join
- Age under 19 years
- Pregnancy
- Cognitive disorder affecting daily activity
- Patients who cannot participate in the survey
- Allergy to the medication
- History of sedative abuse
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Agree, 110-744
About this study
Official title: A Prospective Randomized Controlled Trial on the Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care
The investigators will evaluate the effect of bispectral index-guided titration of sedation during ear surgery under monitored anesthesia care on participant's satisfaction with anesthesia, as well as side effects caused by the anesthetics.
- Being tested
- Titration under the guidance of BIS, Titration under the guidance of OAA/S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration under the guidance of BISDevice
The infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if BIS is greater than 80; The infusion rate is decreased by 0.1mcg/kg/h if BIS is less than 60.
Titration under the guidance of OAA/SDiagnostic test
The infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if OAA/S is greater than 3; The infusion rate is decreased by 0.1mcg/kg/h if OAA/S is less than 3.
| Study group | Role | What they receive |
|---|---|---|
| OAA/S | Active comparator | The patients in the control group will receive MAC titrated according to observer's assessment of anesthesia/sedation(OAA/S) score. Receives: Diagnostic Test: Titration under the guidance of OAA/S |
| BIS | Active comparator | The patients in the control group will receive MAC titrated according to bispectral index(BIS). Receives: Device: Titration under the guidance of BIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iowa Satisfaction with Anesthesia Scale(ISAS)
Patient's satisfaction with MAC
Measured: within 30 minutes after the end of surgery (in the PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start15 Aug 2017
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Why it stopped: extremely slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bispectral Index, Monitored Anesthesia CareStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Geol Ryu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410082
- Sponsor's protocol ID
- snuhksm
- Acronym
- BISMAC
- Status last verified
- Sep 2019
- First submitted
- 26 Jul 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial on the Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care
- ClinicalTrials.gov ID
- NCT03410082
- Acronym / sponsor ID
- BISMAC / snuhksm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: extremely slow enrollment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 25 Jan 2018 (actual)
- 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 investigators will evaluate the effect of bispectral index-guided titration of sedation during ear surgery under monitored anesthesia care on participant's satisfaction with anesthesia, as well as side effects caused by the anesthetics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| OAA/S | Active comparator | Diagnostic Test: Titration under the guidance of OAA/SThe patients in the control group will receive MAC titrated according to observer's assessment of anesthesia/sedation(OAA/S) score. |
| BIS | Active comparator | Device: Titration under the guidance of BISThe patients in the control group will receive MAC titrated according to bispectral index(BIS). |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving ear surgery with ASA physical status 1 or 2
Key exclusion criteria (6 listed)
- Age under 19 years
- Pregnancy
- Cognitive disorder affecting daily activity
- Patients who cannot participate in the survey
- Allergy to the medication
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 |
|---|---|---|
| Titration under the guidance of BISThe infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if BIS is greater than 80; The infusion rate is decreased by 0.1mcg/kg/h if BIS is less than 60. | Device | BIS |
| Titration under the guidance of OAA/SThe infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if OAA/S is greater than 3; The infusion rate is decreased by 0.1mcg/kg/h if OAA/S is less than 3. | Diagnostic test | OAA/S |
Primary outcome
Iowa Satisfaction with Anesthesia Scale(ISAS)
Time frame: within 30 minutes after the end of surgery (in the PACU)
Patient's satisfaction with MAC
Results and safety
The study was stopped early (reason given: extremely slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titration under the guidance of BIS and Titration under the guidance of OAA/S in people with Bispectral Index, Monitored Anesthesia Care, run by Seoul National University Hospital 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 25 Sep 2019. 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?
The study was stopped early (reason given: extremely slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iowa Satisfaction with Anesthesia Scale(ISAS) (time frame: within 30 minutes after the end of surgery (in the PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2019.