The Measurement of Intraocular Pressure in Normal Children Under General Anesthesia With and Without Nitrous Oxide and Anesthetic Eye Drops (IOP)
Primary Purpose
Glaucoma, Intraocular Pressure, Anesthesia
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tono-pen XL Applanation tonometer + Ocu-film +
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma focused on measuring Pediatric glaucoma, Intraocular pressure, pediatric glaucoma diagnosis, Volatiles and intraocular pressure, nitrous oxide, Tetracaine
Eligibility Criteria
Inclusion Criteria:
- male or female from 1 year of age to less than 18 years of age
- Out-patients scheduled to undergo examination under anesthesia
- out-patients scheduled to undergo eye surgery for strabismus or oculoplastic procedure.
- ASA status I or II
- female patients who have attained menarche must have negative pregnancy tests at screening
Exclusion Criteria:
- patients that have contraindications to the use of nitrous oxide in oxygen
- glaucoma patients
- patients in whom IOP cannot be measured accurately
- latex allergy patients
- patients allergic to aminoesthers
Sites / Locations
- University of Miami Bascom Palmer Eye Hospital
- Bascom Palmer Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sevoflurane, oxygen, intraocular pressure
Nitrous oxide/O2/tetracaine
Arm Description
Intraocular measurements under induction with Sevoflurane in oxygen
intraocular pressures in children undergoing inhalation induction with nitrous oxide in oxygen
Outcomes
Primary Outcome Measures
Measurement of intraocular pressure in nonglaucomatous children under Nitrous oxide/Oxygen/topical anesthesia and Nitrous oxide/Sevoflurane/oxygen/Topical anesthesia.
The investigator's intention is to measure IOP in children, who otherwise will be undergoing elective surgery, under nitrous oxide in oxygen and compare those measurements with those going under anesthesia with Sevoflurane in oxygen. The investigators hypothesize that children pre-sedated for surgery,cooperate with topical eye anesthetics and nitrous oxide in oxygen for IOP measurements and results may reflect pre-anesthetic baseline pressures when compared with an induction with Sevoflurane in oxygen.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01925391
Brief Title
The Measurement of Intraocular Pressure in Normal Children Under General Anesthesia With and Without Nitrous Oxide and Anesthetic Eye Drops
Acronym
IOP
Official Title
The Measurement of Intraocular Pressure in Nonglaucomatous Children Under Nitrous Oxide/02/Topical Anesthesia and Sevoflurane/Nitrous Oxide/Topical Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the eye is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the optic nerve, cornea and other structures. Accurate intraocular pressure measurements in young children is often impossible to obtain in an office setting. Children need sedation or general anesthesia to determine IOP. All volatile general anesthetics affect the IOP. Nitrous Oxide, a weak volatile anesthetic, does not affect IOP in healthy adults. Since Nitrous Oxide has shown to be safe and effective in a variety of practice environments, we want to evaluate the use of nitrous oxide in oxygen to obtain IOP measurements in children.
Detailed Description
The investigator's intention is to measure the IOP under nitrous oxide in Oxygen followed by measurements under Sevoflurane in a population of children without glaucoma who are already scheduled to undergo general anesthesia for an elective eye surgery. Normally, induction and maintenance of general anesthesia in children includes the addition of volatile anesthetics such as Sevoflurane. The investigators hypothesize that in children, Nitrous oxide will affect IOP from pre-anesthetic baseline minimally. Hence, when sequential IOP measurements are taken in short intervals ( every 30 seconds times 3), there will be minimal changes during the initial nitrous oxide phase of the induction when compared to the subsequent addition of Sevoflurane.
Subject's parents will be consented and if the subject is old enough to understand the procedure, we will have them also sign an assent to the participation of this study.The child will be randomized to either the nitrous oxide in oxygen and Sevoflurane group or the Nitrous oxide in oxygen alone group or Sevoflurane in oxygen group without Nitrous oxide in the inhalational anesthetic mix.
Subjects will be pre-treated with midazolam via oral administration as a dose of 0.5 - 1 mg/kg not to exceed 20 mg total. If they present with an intravenous line, they will be pre-treated with midazolam at 0.05 - 0.1 mg/kg. All patients receiving preoperative sedation will be monitored as per ASA procedural sedation guidelines.
Once the subject is bought into the operating room, all ASA mandatory vital sign monitors will be connected and tetracaine eye drops ( a fast acting topical anesthetic solution) will be placed on the subject's right eye. The rapid clearance of this short acting topical anesthetic reduces any potential risk for systemic toxicity. Once the drops are in,inhalation induction will begin and an initial attempt at measuring IOP will begin when the pediatric anesthesiologist deems the patient is ready clinically.all vital signs and IOP Measurements will be repeated every 30 seconds three times and recorded for data analysis. Once these measurements are recorded, the case will proceed as scheduled and planned.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Intraocular Pressure, Anesthesia
Keywords
Pediatric glaucoma, Intraocular pressure, pediatric glaucoma diagnosis, Volatiles and intraocular pressure, nitrous oxide, Tetracaine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane, oxygen, intraocular pressure
Arm Type
Active Comparator
Arm Description
Intraocular measurements under induction with Sevoflurane in oxygen
Arm Title
Nitrous oxide/O2/tetracaine
Arm Type
Active Comparator
Arm Description
intraocular pressures in children undergoing inhalation induction with nitrous oxide in oxygen
Intervention Type
Drug
Intervention Name(s)
Tono-pen XL Applanation tonometer + Ocu-film +
Other Intervention Name(s)
Tono-pen Applanation tonometer, Reichert Technologies
Primary Outcome Measure Information:
Title
Measurement of intraocular pressure in nonglaucomatous children under Nitrous oxide/Oxygen/topical anesthesia and Nitrous oxide/Sevoflurane/oxygen/Topical anesthesia.
Description
The investigator's intention is to measure IOP in children, who otherwise will be undergoing elective surgery, under nitrous oxide in oxygen and compare those measurements with those going under anesthesia with Sevoflurane in oxygen. The investigators hypothesize that children pre-sedated for surgery,cooperate with topical eye anesthetics and nitrous oxide in oxygen for IOP measurements and results may reflect pre-anesthetic baseline pressures when compared with an induction with Sevoflurane in oxygen.
Time Frame
Up to 40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
male or female from 1 year of age to less than 18 years of age
Out-patients scheduled to undergo examination under anesthesia
out-patients scheduled to undergo eye surgery for strabismus or oculoplastic procedure.
ASA status I or II
female patients who have attained menarche must have negative pregnancy tests at screening
Exclusion Criteria:
patients that have contraindications to the use of nitrous oxide in oxygen
glaucoma patients
patients in whom IOP cannot be measured accurately
latex allergy patients
patients allergic to aminoesthers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline L tutiven, Md
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Bascom Palmer Eye Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Bascom Palmer Eye Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33138
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Measurement of Intraocular Pressure in Normal Children Under General Anesthesia With and Without Nitrous Oxide and Anesthetic Eye Drops
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