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Oculocardiac Reflex Brain Wave Monitor (OCRBIS)

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ClinicalTrials.gov Identifier: NCT03663413
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Alaska Blind Child Discovery

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
Bradycardia Strabismus 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.


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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 : August 27, 2009
Actual Primary Completion Date : November 21, 2013
Actual Study Completion Date : November 21, 2013

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 Name: 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 Name: brain wave




Primary Outcome Measures :
  1. heart rate change [ Time Frame: intraoperative 10 seconds ]
    bradycardia with extra ocular muscle tension



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
strabismus surgery
Criteria

Inclusion Criteria:

  • all

Exclusion Criteria:

  • those receiving anticholinergic medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663413


Sponsors and Collaborators
Alaska Blind Child Discovery
Investigators
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Principal Investigator: Robert W Arnold, MD Alaska Childrens EYE & Strabismus

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alaska Blind Child Discovery
ClinicalTrials.gov Identifier: NCT03663413     History of Changes
Other Study ID Numbers: ABCD OCR BIS
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: de-identified data base stored.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Strabismus
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases