Phase 4
N=106
The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.
Strabismus
Bottom Line
View on ClinicalTrials.gov: NCT03349515 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Breath Duration — 2.14; 2.18; 2.26; 2.15 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Provodine-Iodine Solution (Drug); Group B will receive three drops in each eye of ophthalmic balanced salt solution. (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breath Duration |
2.14; 2.18; 2.26; 2.15; 5.02; 2.18 | — |
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.
Eligibility Criteria
- Inclusion Criteria
- Children between the ages of 1 year and 17 years
- Scheduled for strabismus surgery
- Anesthesia plan includes inhalational induction with sevoflurane and the use of a laryngeal mask airway (LMA) with spontaneous ventilation, per the attending anesthesiologist.
Exclusion Criteria
- History of an adverse reaction to iodine
- History of any thyroid disease
- Patients who require tracheal intubation, as determined by the attending anesthesiologist; e.g. craniofacial anomalies.
- Patients with a contraindication to sevoflurane, such as malignant hyperthermia or severe left ventricular dysfunction.
- Inability or unwillingness of the subject or legal guardian/ representative to give informed consent.
Data sourced from ClinicalTrials.gov (NCT03349515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.