The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.

Phase 4

Completed

• Conditions: Strabismus
• Interventions: Drug: Provodine-Iodine Solution; Drug: Group B will receive three drops in each eye of ophthalmic balanced salt solution.

• Registration Number: NCT03349515
• Lead Sponsor: Medical University of South Carolina

Brief Summary

Determine whether the application of povidone-iodine ophthalmic solution onto the ocular surface causes a change in respiration in children undergoing strabismus surgery with general anesthesia.

Hypothesis: The application of povidone-iodine ophthalmic solution to the ocular surface causes a change in respiration in children during general anesthesia prior to strabismus surgery.

Detailed Description

The study is randomized and single blind. One hundred children were randomly assigned to have either povidone-iodine (group A) or balanced salt solution (BSS) (group B) eye drops instilled into their eyes during anesthesia just prior to strabismus surgery. After induction of anesthesia and insertion of an LMA while the patient was at a steady state of anesthesia and spontaneously breathing sevoflurane in oxygen, 3 drops of either povidone-iodine or BSS was instilled into each eye (right eye first). Respiratory rate was determined by measuring the peak-to-peak interval on the capnograph. This is similar to calculating heart rate by measuring the R-R interval on an ECG. HR, BP, SaO2, EtCO2, and expired sevoflurane were measured in each patient. Medical history information collected included history of prior surgeries, co-existing diseases, or apnea. Appropriate statistical analyses were performed for comparisons between the groups with respect to respiratory rate, HR, BP, expired sevoflurane, and co-existing diseases.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-23
• Study Start: 2017-11-02
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-21
• Primary Completion: 2018-09-19
• Study Completion: 2018-09-19
• Results First Submitted: 2019-07-25
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-13
• Last Update Submitted: 2019-09-13
• Results First Posted: 2019-09-16
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - povidone-iodine ophthalmic solution.	Provodine-Iodine Solution	Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first.
Group B - ophthalmic balanced salt solution.	Group B will receive three drops in each eye of ophthalmic balanced salt solution.	Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.

Primary Outcome Measures

Name	Time	Method
Breath Duration	5 minutes	The iPhone stopwatch application will be used and its 'lap button' feature to collect the respiration peak intervals (in seconds) for 5 breaths. Specifically, at the patient's peak inspiration (as seen on the capnography), the study member will start the stopwatch and proceed to hit the 'lap' button for the next 5 consecutive inspiration peaks. These data intervals will be recorded on the data sheet after the 5 breaths are over, as the intervals are conveniently stored and numbered below the stopwatch in the app

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States