BradycardiaOCRBISNCT03663413
Oculocardiac Reflex Brain Wave Monitor
An observational study of Bradycardia and Strabismus, run by Alaska Blind Child Discovery.
Trial summary
Oculocardiac reflex during routine strabismus surgery was prospectively observed in association with routine brain wave monitoring. Providence Hospital institutional review board (IRB) approved this observational study without need for consent. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Bradycardia, Strabismus
- What is being tested?
- non-invasive monitor
- Type of treatment
- Medical device
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2009to 21 Nov 2013
- Phase
- Observational
- 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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: strabismus surgery
Who may be able to join
- all
Who cannot join
- those receiving anticholinergic medications
About this study
Official title: The Oculocardiac Reflex Influenced at Different Levels of Brain Wave Monitoring
Oculocardiac reflex during routine strabismus surgery was prospectively observed in association with routine brain wave monitoring.
Providence Hospital institutional review board (IRB) approved this observational study without need for consent.
Read the detailed description
Introduction: The oculocardiac reflex (OCR), bradycardia that occurs during strabismus surgery, is blocked by anticholinergics and enhanced by opioids and dexmedetomidine. Two recent studies suggest that deeper inhalational anesthesia monitored by bispectral index (BIS) protects against OCR; the investigators wondered if our data correlated similarly.
Methods: In an ongoing, prospective study of OCR elicited by 10-second, 200 gram square-wave traction on extraocular muscles (EOM) from 2009 to 2013, anesthetic depth was estimated in cohorts using either BIS or Narcotrend monitors. The depth of anesthesia was deliberately varied between first and second EOM tested.
- Conditions
- Bradycardia, Strabismus
- Being tested
- non-invasive monitor
- Medical subject headings
- Bradycardia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive monitorDevice
Also called brain wave
cutaneous EEG monitor
| Study group | Role | What they receive |
|---|---|---|
| BIS | Monitored with BIS (bispectral index) monitor in addition to other conventional monitors of blood pressure, ECG, oxygen saturation and anesthetic agent concentration. Receives: Device: non-invasive monitor | |
| Narcotrend | Monitored with Narcotrend monitor in addition to other conventional monitors of blood pressure, ECG, oxygen saturation and anesthetic agent concentration. Receives: Device: non-invasive monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate change
bradycardia with extra ocular muscle tension
Measured: intraoperative 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start27 Aug 2009
- Primary completion21 Nov 2013
- Study completion21 Nov 2013
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 BradycardiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaska Blind Child Discovery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert W Arnold, MD, Principal investigator, Alaska Childrens EYE & Strabismus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663413
- Sponsor's protocol ID
- ABCD OCR BIS
- Acronym
- OCRBIS
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: de-identified data base stored.
Publications
Arnold RW, Biggs RE, Beerle BJ. Intravenous dexmedetomidine augments the oculocardiac reflex. J AAPOS. 2018 Jun;22(3):211-213.e1. doi: 10.1016/j.jaapos.2018.01.016. Epub 2018 May 5.
PubMed 29733898Arnold RW, Bond AN, McCall M, Lunoe L. The oculocardiac reflex and depth of anesthesia measured by brain wave. BMC Anesthesiol. 2019 Mar 14;19(1):36. doi: 10.1186/s12871-019-0712-z.
PubMed 30871507
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oculocardiac Reflex Influenced at Different Levels of Brain Wave Monitoring
- ClinicalTrials.gov ID
- NCT03663413
- Acronym / sponsor ID
- OCRBIS / ABCD OCR BIS
- Conditions
- Bradycardia, Strabismus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Alaska Blind Child DiscoveryUniversity, hospital or other
- Study start
- 27 Aug 2009 (actual)
- Primary completion
- 21 Nov 2013 (actual)
- Study completion
- 21 Nov 2013 (actual)
- First posted
- 10 Sep 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.
Oculocardiac reflex during routine strabismus surgery was prospectively observed in association with routine brain wave monitoring.
Providence Hospital institutional review board (IRB) approved this observational study without need for consent.
Detailed description
Introduction: The oculocardiac reflex (OCR), bradycardia that occurs during strabismus surgery, is blocked by anticholinergics and enhanced by opioids and dexmedetomidine. Two recent studies suggest that deeper inhalational anesthesia monitored by bispectral index (BIS) protects against OCR; the investigators wondered if our data correlated similarly.
Methods: In an ongoing, prospective study of OCR elicited by 10-second, 200 gram square-wave traction on extraocular muscles (EOM) from 2009 to 2013, anesthetic depth was estimated in cohorts using either BIS or Narcotrend monitors. The depth of anesthesia was deliberately varied between first and second EOM tested.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS | – | Device: non-invasive monitorMonitored with BIS (bispectral index) monitor in addition to other conventional monitors of blood pressure, ECG, oxygen saturation and anesthetic agent concentration. |
| Narcotrend | – | Device: non-invasive monitorMonitored with Narcotrend monitor in addition to other conventional monitors of blood pressure, ECG, oxygen saturation and anesthetic agent concentration. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- strabismus surgery
Key inclusion criteria (1 listed)
- all
Key exclusion criteria (1 listed)
- those receiving anticholinergic medications
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 |
|---|---|---|
| non-invasive monitorAlso: brain wavecutaneous EEG monitor | Device | BIS, Narcotrend |
Primary outcome
heart rate change
Time frame: intraoperative 10 seconds
bradycardia with extra ocular muscle tension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 29733898Arnold RW, Biggs RE, Beerle BJ. Intravenous dexmedetomidine augments the oculocardiac reflex. J AAPOS. 2018 Jun;22(3):211-213.e1. doi: 10.1016/j.jaapos.2018.01.016. Epub 2018 May 5.
- Background: PubMed 30871507Arnold RW, Bond AN, McCall M, Lunoe L. The oculocardiac reflex and depth of anesthesia measured by brain wave. BMC Anesthesiol. 2019 Mar 14;19(1):36. doi: 10.1186/s12871-019-0712-z.
- Individual participant dataSharing planned: Undecided. de-identified data base stored.
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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.
Robert W Arnold, MD principal investigator
Alaska Childrens EYE & Strabismus
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Strabismus, run by Alaska Blind Child Discovery.
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 1 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: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
heart rate change (time frame: intraoperative 10 seconds). 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 NCT03663413, 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 19 Oct 2020.