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

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ClinicalTrials.gov Identifier: NCT03349515
Recruitment Status : Completed
First Posted : November 21, 2017
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Michelle Rovner, MD, Medical University of South Carolina

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.

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.


Condition or disease Intervention/treatment Phase
Strabismus Drug: Provodine-Iodine Solution Drug: Group B will receive three drops in each eye of ophthalmic balanced salt solution. Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
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
Official Title: The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.
Actual Study Start Date : November 2, 2017
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : September 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A - povidone-iodine ophthalmic solution.
Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first.
Drug: Provodine-Iodine Solution
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.

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




Primary Outcome Measures :
  1. Breath Duration [ Time Frame: 5 minutes ]
    The iPhone stopwatch application will be used and its 'lap button' feature to collect the respiration peak intervals (in seconds) for 5 breaths. Specifically, at the patient's peak inspiration (as seen on the capnography), the study member will start the stopwatch and proceed to hit the 'lap' button for the next 5 consecutive inspiration peaks. These data intervals will be recorded on the data sheet after the 5 breaths are over, as the intervals are conveniently stored and numbered below the stopwatch in the app



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349515


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Michelle Rovner, MD, Medical University of South Carolina:
Study Protocol  [PDF] August 15, 2018
Statistical Analysis Plan  [PDF] August 15, 2018

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Responsible Party: Michelle Rovner, MD, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03349515    
Other Study ID Numbers: Pro00067331
First Posted: November 21, 2017    Key Record Dates
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Pharmaceutical Solutions