Phase 4
Completed N=106
The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.
Strabismus
Source: ClinicalTrials.gov NCT03349515 ↗
Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Breath Duration — 2.14; 2.18; 2.26; 2.15 seconds
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breath Duration |
2.14; 2.18; 2.26; 2.15; 5.02; 2.18 | — |
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. Informational only — not medical advice.