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OCRBIS: Oculocardiac Reflex Brain Wave Monitor

Sponsor
Alaska Blind Child Discovery (Other)
Overall Status
Completed
CT.gov ID
NCT03663413
Collaborator
(none)
188
Enrollment
50.8
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: non-invasive monitor

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

Study Type:
Observational
Actual Enrollment :
188 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Oculocardiac Reflex Influenced at Different Levels of Brain Wave Monitoring
Actual Study Start Date :
Aug 27, 2009
Actual Primary Completion Date :
Nov 21, 2013
Actual Study Completion Date :
Nov 21, 2013

Arms and Interventions

Arm Intervention/Treatment
BIS

Monitored with BIS (bispectral index) monitor in addition to other conventional monitors of blood pressure, ECG, oxygen saturation and anesthetic agent concentration.

Device: non-invasive monitor
cutaneous EEG monitor
Other Names:
  • brain wave

    		•
    Narcotrend

    Monitored with Narcotrend monitor in addition to other conventional monitors of blood pressure, ECG, oxygen saturation and anesthetic agent concentration.

    Device: non-invasive monitor
    cutaneous EEG monitor
    Other Names:
  • brain wave

    		•

    Outcome Measures

    Primary Outcome Measures

    1. heart rate change [intraoperative 10 seconds]

      bradycardia with extra ocular muscle tension

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all
    Exclusion Criteria:
    • those receiving anticholinergic medications

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alaska Blind Child Discovery

    Investigators

    • Principal Investigator: Robert W Arnold, MD, Alaska Childrens EYE & Strabismus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alaska Blind Child Discovery
    ClinicalTrials.gov Identifier:
    NCT03663413
    Other Study ID Numbers:
    • ABCD OCR BIS
    First Posted:
    Sep 10, 2018
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Strabismus
    Bradycardia

    Study Results

    No Results Posted as of Oct 19, 2020