Strabismus
Conditions
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.
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.
Interventions
DRUGProvodine-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.
DRUGGroup 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
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
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
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Physician Decision | 3 | 1 |
Baseline characteristics
| Characteristic | Total | Group A - Povidone-iodine Ophthalmic Solution. | Group B - Ophthalmic Balanced Salt Solution. |
|---|---|---|---|
| Age, Categorical <=18 years | 100 Participants | 50 Participants | 50 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.31 years STANDARD_DEVIATION 3.61 | 6.2 years STANDARD_DEVIATION 3.9 | 6.4 years STANDARD_DEVIATION 3.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants | 47 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 73 Participants | 38 Participants | 35 Participants |
| Region of Enrollment United States | 100 participants | 50 participants | 50 participants |
| Sex: Female, Male Female | 60 Participants | 33 Participants | 27 Participants |
| Sex: Female, Male Male | 40 Participants | 17 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 51 |
| other Total, other adverse events | 0 / 55 | 0 / 51 |
| serious Total, serious adverse events | 0 / 55 | 0 / 51 |
Outcome results
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
Time frame: 5 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 10 | 2.49 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 3 | 5.02 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 5 | 3.08 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 15 | 2.09 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 6 | 7.47 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 11 | 2.35 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 7 | 3.22 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 4 | 5.65 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 9 | 2.69 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 13 | 2.12 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 2 | 2.26 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 14 | 2.14 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 12 | 2.15 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 1 | 2.14 seconds | Standard Error 0.621 |
| Group A - Povidone-iodine Ophthalmic Solution. | Breath Duration | Breath 8 | 2.49 seconds | Standard Error 0.621 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 1 | 2.18 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 8 | 2.17 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 9 | 2.21 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 11 | 2.2 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 12 | 2.17 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 15 | 2.09 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 4 | 2.23 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 3 | 2.18 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 2 | 2.15 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 5 | 2.22 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 6 | 2.25 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 7 | 2.20 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 10 | 2.15 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 13 | 2.16 seconds | Standard Error 0.626 |
| Group B - Ophthalmic Balanced Salt Solution. | Breath Duration | Breath 14 | 2.18 seconds | Standard Error 0.626 |