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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. The eye drops will be administered by the study anesthesiologist. |
| FG001 | Group B - Ophthalmic Balanced Salt Solution. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2018 | Sep 9, 2019 |
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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
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| 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 |
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Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | There were 6 patients withdrawn. 5 from Group A and 1 from Group B | Count of Participants | Participants |
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| Age, Continuous | There were 6 participants withdrawn. 5 from Group A and 1 from Group B. | Mean | Standard Deviation | years |
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| Sex: Female, Male | There were 6 participants withdrawn. 5 from Group A and 1 from Group B. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B. | Count of Participants | Participants |
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| Race (NIH/OMB) | There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B. | Count of Participants | Participants |
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| Region of Enrollment | There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | seconds | 5 minutes |
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Adverse event data was collected during the participants surgery when eye drops were placed. This time frame was less than 30 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 55 | 0 | 55 | 0 | 55 |
| EG001 | 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. | 0 | 51 | 0 | 51 | 0 | 51 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Rovner | Medical University of South Carolina | 843-792-2322 | rovner@musc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2018 | Sep 9, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013285 | Strabismus |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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