Skip to main content
OpenTrials
Completed

NCT Number: NCT03663413

Oculocardiac Reflex Brain Wave Monitor

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Heart Diseases Nervous System Diseases Ocular Motility Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Strabismus

Age range

3 month and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all

Exclusion criteria

  • those receiving anticholinergic medications

Treatment and study plan

non-invasive monitor

Device

cutaneous EEG monitor

Other names: brain wave

Primary outcomes

  1. heart rate change

    Time frame: intraoperative 10 seconds

    bradycardia with extra ocular muscle tension

Sponsors and collaborators

Lead sponsor

Alaska Blind Child Discovery

Other

Registry information

Official study title

The Oculocardiac Reflex Influenced at Different Levels of Brain Wave Monitoring

Acronym: OCRBIS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.