NCT03663413

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2013

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2018

Enrollment Period

4.2 years

First QC Date

September 5, 2018

Last Update Submit

October 14, 2020

Conditions

BradycardiaStrabismus

Outcome Measures

Primary Outcomes (1)

  • heart rate change

    bradycardia with extra ocular muscle tension

    intraoperative 10 seconds

Study Arms (2)

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

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

Interventions

non-invasive monitorDEVICE

cutaneous EEG monitor

Also known as: brain wave
BISNarcotrend

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

strabismus surgery

You may qualify if:

  • all

You may not qualify if:

  • those receiving anticholinergic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 29733898BACKGROUND

  • 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.

    PMID: 30871507BACKGROUND

MeSH Terms

Conditions

BradycardiaStrabismus

Interventions

Brain Waves

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ElectroencephalographyDiagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisElectrophysiological PhenomenaPhysiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert W Arnold, MD

    Alaska Childrens EYE & Strabismus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 10, 2018

Study Start

August 27, 2009

Primary Completion

November 21, 2013

Study Completion

November 21, 2013

Last Updated

October 19, 2020

Record last verified: 2018-09