Effect of Sevoflurane Concentration on Intraocular Pressure in Surgical Children With Healthy Eyes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01248689
First received: November 17, 2010
Last updated: November 23, 2010
Last verified: November 2010
  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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248689

Contacts
Contact: Idit Matot, MD 97236974758 iditm@tasmc.health.gov.il

Locations
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         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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 September 14, 2014