Status:
COMPLETED
The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.
Lead Sponsor:
Medical University of South Carolina
Conditions:
Strabismus
Eligibility:
All Genders
1-17 years
Phase:
PHASE4
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. Hypo...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2018
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03349515
Start Date
November 2 2017
End Date
September 19 2018
Last Update
September 16 2019
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425