The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 4

Conditions: Strabismus

Treatments: Drug: Provodine-Iodine Solution; Drug: Group B will receive three drops in each eye of ophthalmic balanced salt solution.

Study type: Interventional

Funder types: Other

Identifiers

NCT03349515

Pro00067331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Group A - povidone-iodine ophthalmic solution.

Active Comparator group

Description:

Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first.

Treatment:

Drug: Provodine-Iodine Solution

Group B - ophthalmic balanced salt solution.

Active Comparator group

Description:

Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.

Treatment:

Drug: Group B will receive three drops in each eye of ophthalmic balanced salt solution.