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

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT03349515
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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 statisticianGroup 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: Nov 2, 2017
• Actual Primary Completion Date: Sep 19, 2018
• Actual Study Completion Date: Sep 19, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Breath Duration [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 15, 2018
• Statistical Analysis Plan - Aug 15, 2018

More Information

Publications

None provided.

• Responsible Party: Michelle Rovner, MD, Assistant Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03349515
• Other Study ID Numbers: Pro00067331
• First Posted: Nov 21, 2017
• Last Update Posted: Sep 16, 2019
• Last Verified: Sep 1, 2019

• 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: Strabismus; Pharmaceutical Solutions

Study Results

Participant Flow

Arm/Group Title	Group A - Povidone-iodine Ophthalmic Solution.	Group B - Ophthalmic Balanced Salt Solution.
Arm/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. The eye drops will be administered by the study anesthesiologist.	Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.
Period Title: Overall Study
STARTED	55	51
COMPLETED	50	50
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	Group A - Povidone-iodine Ophthalmic Solution.	Group B - Ophthalmic Balanced Salt Solution.	Total
Arm/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.	Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.	Total of all reporting groups
Overall Participants	50	50	100
Age (Count of Participants)
<=18 years	50 100%	50 100%	100 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	6.2 (3.9)	6.4 (3.4)	6.31 (3.61)
Sex: Female, Male (Count of Participants)
Female	33 66%	27 54%	60 60%
Male	17 34%	23 46%	40 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 6%	2 4%	5 5%
Not Hispanic or Latino	47 94%	48 96%	95 95%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2%	0 0%	1 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 16%	12 24%	20 20%
White	38 76%	35 70%	73 73%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 6%	3 6%	6 6%
Region of Enrollment (participants) [Number]
United States	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Breath Duration
Description	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
Time Frame	5 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A - Povidone-iodine Ophthalmic Solution.	Group B - Ophthalmic Balanced Salt Solution.
Arm/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. 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 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
Measure Participants	50	50
Breath 1	2.14 (0.621)	2.18 (0.626)
Breath 2	2.26 (0.621)	2.15 (0.626)
Breath 3	5.02 (0.621)	2.18 (0.626)
Breath 4	5.65 (0.621)	2.23 (0.626)
Breath 5	3.08 (0.621)	2.22 (0.626)
Breath 6	7.47 (0.621)	2.25 (0.626)
Breath 7	3.22 (0.621)	2.20 (0.626)
Breath 8	2.49 (0.621)	2.17 (0.626)
Breath 9	2.69 (0.621)	2.21 (0.626)
Breath 10	2.49 (0.621)	2.15 (0.626)
Breath 11	2.35 (0.621)	2.2 (0.626)
Breath 12	2.15 (0.621)	2.17 (0.626)
Breath 13	2.12 (0.621)	2.16 (0.626)
Breath 14	2.14 (0.621)	2.18 (0.626)
Breath 15	2.09 (0.621)	2.09 (0.626)

Adverse Events

Time Frame	Adverse event data was collected during the participants surgery when eye drops were placed. This time frame was less than 30 minutes.
Arm/Group Title	Group A - Povidone-iodine Ophthalmic Solution.		Group B - Ophthalmic Balanced Salt Solution.
Arm/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.		Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.
All Cause Mortality
	Group A - Povidone-iodine Ophthalmic Solution.		Group B - Ophthalmic Balanced Salt Solution.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/51 (0%)
Serious Adverse Events
	Group A - Povidone-iodine Ophthalmic Solution.		Group B - Ophthalmic Balanced Salt Solution.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Group A - Povidone-iodine Ophthalmic Solution.		Group B - Ophthalmic Balanced Salt Solution.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.