The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.
Condition: Strabismus
MeSH terms: Strabismus
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Provodine-Iodine Solution; Group B will receive three drops in each eye of ophthalmic balanced salt solution.
Intervention type(s): Drug; Drug
Intervention description(s): 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
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)
Primary purpose: Other