Oculocardiac Reflex Brain Wave Monitor (OCRBIS)

October 14, 2020 updated by: Alaska Blind Child Discovery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

188

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

strabismus surgery

Description

Inclusion Criteria:

  • all

Exclusion Criteria:

  • those receiving anticholinergic medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate change
Time Frame: intraoperative 10 seconds
bradycardia with extra ocular muscle tension
intraoperative 10 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaska Blind Child Discovery

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2009

Primary Completion (Actual)

November 21, 2013

Study Completion (Actual)

November 21, 2013

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCD OCR BIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

de-identified data base stored.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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