Strabismus Recovery With Proparacaine and Oculocardiac Reflex

NCT ID: NCT03672435

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

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-29

Study Completion Date

2013-11-21

Brief Summary

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Observational study to determine if topical anesthetic and intraoperative oculocardiac reflex influence post strabismus surgery recovery.

Detailed Description

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In an observational study with de-identified data of oculocardiac reflex (OCR) and strabismus surgery under routine anesthesia, a cohort of ongoing patients received topical proparacaine immediately post op, or none. Co-variables were intraoperative opioid and OCR, patient age, type of surgery. Several post-operative recovery outcome variables were prospectively monitored.

Conditions

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Strabismus Bradycardia Nausea Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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proparacaine

Received topical proparacaine 0.5% with routine antibiotic-steroid ointment in operative eye(s) following strabismus surgery

Topical Solution

Intervention Type DRUG

proparacaine 0.5% eye drop

No proparacaine

Received no topical proparacaine 0.5% but did receive routine antibiotic-steroid ointment in the operative eye(s) following strabismus surgery

No interventions assigned to this group

Interventions

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Topical Solution

proparacaine 0.5% eye drop

Intervention Type DRUG

Other Intervention Names

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proparacaine

Eligibility Criteria

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Inclusion Criteria

* Strabismus surgery

Exclusion Criteria

* none
Minimum Eligible Age

3 Months

Maximum Eligible Age

90 Years

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 Blind Child Discovery

References

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Arnold RW, Bond AN. Does Topical Proparacaine Improve Postoperative Comfort After Strabismus Surgery? Clin Ophthalmol. 2019 Nov 20;13:2279-2283. doi: 10.2147/OPTH.S230498. eCollection 2019.

Reference Type BACKGROUND
PMID: 31819352 (View on PubMed)

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 RESULT
PMID: 29733898 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

deidentified OCR topical anesthetic recovery outcomes

View Document

Other Identifiers

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ABCD OCR proparacaine

Identifier Type: -

Identifier Source: org_study_id

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