Effect of Sevoflurane Concentration on Intraocular Pressure in Surgical Children With Healthy Eyes
Recruitment status was Not yet recruiting
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Purpose
One important goal in anesthetic management during ocular surgery is to provide adequate control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients with glaucoma or a penetrating open-eye injury. Accurate assessment of IOP is particularly important in infants and children with definite or suspected glaucoma undergoing examination under anesthesia.
Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic agents, such as sevoflurane. Sevoflurane is known to reduce the IOP. During pediatric ocular surgery, the inspired sevoflurane concentration varies continuously and may have an impact over the IOP that could affect the conduct of surgery. In this study the investigators wish to evaluate whether variations in sevoflurane concentration do affect the IOP.
| Condition | Intervention |
|---|---|
|
Intraocular Pressure |
Other: concentration profile 1 Other: concentration profile 2 Other: concentration profile 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science |
| Official Title: | The Effect of Different Concentrations of Sevoflorane on Intraocular Pressure in Children Undergoing Ocular Surgery Under General Anesthesia |
- IOP [ Time Frame: first hour of anesthesia ] [ Designated as safety issue: No ]IOP will be measured in both eyes, after induction of anesthesia and before the onset of surgery
| Estimated Enrollment: | 21 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: concentration profile 1
IOP will be measured under this order of sevoflurane concentrations: 7%, 5%, 2%, 0.5% |
Other: concentration profile 1
IOP will be measured under this order of sevoflurane concentrations: 7%, 5%, 2%, 0.5% Other Name: IOP measurements 1
|
|
Active Comparator: concentration profile 2
IOP will be measured under this order of sevoflurane concentrations: 7%, 2%, 5%, 0.5% |
Other: concentration profile 2
IOP will be measured under this order of sevoflurane concentrations: 7%, 2%, 5%, 0.5% Other Name: IOP measurements 2
|
|
Active Comparator: concentration profile 3
IOP will be measured under this order of sevoflurane concentrations: 7%, 0.5%, 5%, 2% |
Other: concentration profile 3
IOP will be measured under this order of sevoflurane concentrations: 7%, 0.5%, 5%, 2% Other Name: IOP measurements 3
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- children with healthy eyes, undergoing elective surgery for strabismus correction or tear duct probing and irrigation.
Exclusion Criteria:
- children with adverse reaction or contraindication (of any other reason) to sevoflurane or remifentanil, and patients with pre-existing intra-ocular ophthalmic disease, or infection.
Contacts and Locations| Contact: Idit Matot, MD | 97236974758 | iditm@tasmc.health.gov.il |
| Israel | |
| Tel-Aviv Sourasky Medical Center | Not yet recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Yifat Klein, PhD 97236974093 yifat.klein@gmail.com | |
| Principal Investigator: Nina Gofman, MD | |
| Sub-Investigator: Noa Ella-Dalman, MD | |
| Sub-Investigator: Yifat Klein, PhD | |
| Study Chair: | Idit Matot, MD | Tel-Aviv Sourasky Medical Center |
More Information
No publications provided
| Responsible Party: | Professor Idit Matot. Chair, Department of Anesthsiology & Intensive Care, Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01248689 History of Changes |
| Other Study ID Numbers: | TASMC-10-IM-0553-CTIL |
| Study First Received: | November 17, 2010 |
| Last Updated: | November 23, 2010 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Sevoflurane Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Anesthetics, Inhalation |
Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013