Clincosm LogoSign in Get a demo

OCRprop: Strabismus Recovery With Proparacaine and Oculocardiac Reflex

Sponsor
Alaska Blind Child Discovery (Other)
Overall Status
Completed
CT.gov ID
NCT03672435
Collaborator
(none)
140
Enrollment
39.8
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Topical Solution

Detailed Description

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
140 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Does Proparacaine Enhance Strabismus Recovery
Actual Study Start Date :
Jul 29, 2010
Actual Primary Completion Date :
Nov 21, 2013
Actual Study Completion Date :
Nov 21, 2013

Arms and Interventions

Arm Intervention/Treatment
proparacaine

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

Drug: Topical Solution
proparacaine 0.5% eye drop
Other Names:
  • proparacaine

    		•
    No proparacaine

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

    Outcome Measures

    Primary Outcome Measures

    1. pain (post op pain Likert scale) [hours (1-4) in recovery room]

      pain scale description / observation.. Pain is ranked by patient or nurse from 0 (no pain) to 9 (much pain)

    Secondary Outcome Measures

    1. nausea [hours (1-4) in recovery room]

      observed or described nausea (presence or absence of nausea / vomiting)

    2. heart rate [hours (1-4) while in recovery room]

      recovery room heart rate

    3. time to recovery [minutes (30-240) from entry recovery room to discharge]

      time in recovery room

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Strabismus surgery
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alaska Blind Child Discovery

    Investigators

    • Principal Investigator: Robert W Arnold, MD, Alaska Blind Child Discovery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alaska Blind Child Discovery
    ClinicalTrials.gov Identifier:
    NCT03672435
    Other Study ID Numbers:
    • ABCD OCR proparacaine
    First Posted:
    Sep 14, 2018
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Alaska Blind Child Discovery
    post operative recovery
    oculocardiac reflex
    extra ocular muscle
    conjunctiva
    numbing drop
    heart rate
    Additional relevant MeSH terms:
    Strabismus
    Bradycardia
    Proxymetacaine

    Study Results

    No Results Posted as of Oct 19, 2020