Health TrialsbyHealthPanel

The Alaska Oculocardiac Reflex Study

ConditionsBradycardiaStrabismus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-100
SponsorAlaska Blind Child Discovery

About this trial

Observation study monitoring vital signs and anesthetic variables particularly heart rate during prospective, ocular manipulation and specifically uniform tension on extra ocular muscles during strabismus surgery.

\*IRB approval from 1992 covered in letter from then IRB chair Dr. Judith Whitcomb, Anchorage, Alaska (letter 10/2020).\*

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient scheduled for ocular manipulation and tension on extra ocular muscles and strabismus surgery

Disqualifiers

anophthalmia

Trial population

Adults and children undergoing ocular manipulation and tension on extra ocular muscles and strabismus surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • electrocardiograph

    Diagnostic test

    electrocardiograph monitor during strabismus surgery

Treatment groups

4,000 Participants
are divided into 2 treatment groups
Group A: anticholinergic1 intervention
Group B: non-anticholinergic1 intervention

Trial outcomes

Primary outcomes

1

Percent heart rate resulting from oculocardiac reflex

Continuous variable of percent change in heart rate from stable pre-heart rate to greatest change heart rate during strabismus surgery

Time frame
30 seconds

Secondary outcomes

1

Anesthetic interventions

Impact of existing and emerging anesthetics on oculocardiac reflex. This shall include various existing and emerging medications and inhalation agents, dosage, routes, airway types, general anesthesia and awake, and monitor methods.

Time frame
2 hours
2

Patient Characteristics

The impact of various patient characteristics on oculocardiac reflex including patient age, weight, gender and race, the presence of neuro-developmental condition.

Time frame
2 hours
3

Surgeon Interventions

The impact of various aspects/phases of ocular manipulation and/or surgical technique. This includes monitored electrocardiograph during insertion of lid speculum, pressure on the globe, grasping of conjunctiva, incision of conjunctiva, dissection of Tenon's capsule, traction on extra ocular muscle, suturing extra ocular muscle, disinsertion of extra ocular muscle, re-suturing of extra ocular muscle and closure of conjunctiva.

Time frame
2 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alaska Blind Child Discovery

Lead sponsor

Source ClinicalTrials.gov
Apply now