Oculocardiac Reflex Brain Wave Monitor

Bradycardia Clinical Trial

— OCRBIS  

Official title:

The Oculocardiac Reflex Influenced at Different Levels of Brain Wave Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663413
• Other study ID #: ABCD OCR BIS
• Status: Completed
• Start date: August 27, 2009
• Est. completion date: November 21, 2013

Study information

• Verified date: September 2018
• Source: Alaska Blind Child Discovery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: November 21, 2013
• Est. primary completion date: November 21, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

• all

Exclusion Criteria:

• those receiving anticholinergic medications

Related Conditions & MeSH terms

• Bradycardia
• Strabismus

Intervention

Device:
• non-invasive monitor
cutaneous EEG monitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alaska Blind Child Discovery

References & Publications (2)

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. — View Citation

Arnold 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate change	bradycardia with extra ocular muscle tension	intraoperative 10 seconds