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

NCT03349515 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00067331
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Strabismus

Outcome Measures

Primary Outcomes (1)

• Breath Duration

  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

  5 minutes

Study Arms (2)

Group A - povidone-iodine ophthalmic solution.

ACTIVE COMPARATOR

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 B - ophthalmic balanced salt solution.

ACTIVE COMPARATOR

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.

Interventions

Provodine-Iodine Solution DRUG

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 A - povidone-iodine ophthalmic solution.

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

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

Group B - ophthalmic balanced salt solution.

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Michelle Rovner
• Organization: Medical University of South Carolina

rovner@musc.edu

843-792-2322

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 21, 2017
• Study Start: November 2, 2017
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-09

Locations

US (1)