Oculocardiac Reflex Brain Wave Monitor

NCT ID: NCT03663413

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-27

Study Completion Date

2013-11-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bradycardia Strabismus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BIS

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

non-invasive monitor

Intervention Type DEVICE

cutaneous EEG monitor

Narcotrend

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

non-invasive monitor

Intervention Type DEVICE

cutaneous EEG monitor

Interventions

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non-invasive monitor

cutaneous EEG monitor

Intervention Type DEVICE

Other Intervention Names

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brain wave

Eligibility Criteria

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Inclusion Criteria

* all

Exclusion Criteria

* those receiving anticholinergic medications
Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alaska Blind Child Discovery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert W Arnold, MD

Role: PRINCIPAL_INVESTIGATOR

Alaska Childrens EYE & Strabismus

References

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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.

Reference Type BACKGROUND
PMID: 29733898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30871507 (View on PubMed)

Other Identifiers

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ABCD OCR BIS

Identifier Type: -

Identifier Source: org_study_id

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