The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.
Condition: Strabismus
MeSH terms: Strabismus
Intervention: Provodine-Iodine Solution; Group B will receive three drops in each eye of ophthalmic balanced salt solution.
Intervention description: Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes.; Group B will receive three drops in each eye of ophthalmic balanced salt solution. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A - povidone-iodine ophthalmic solution, or Group B - ophthalmic balanced salt solution. This randomization will be determined using a simple randomization scheme provided by the study's statistician
Masking: Single (Participant)
Enrollment: 106.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

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.