The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 1 - 17 |
Updated: | 2/8/2019 |
Start Date: | November 2, 2017 |
End Date: | September 19, 2018 |
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.
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.
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.
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.
- 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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Michelle Rovner, MD
Phone: 843-792-2322
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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