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

NCT01248689 | Unknown

• 1 other identifier: TASMC-10-IM-0553-CTIL
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• IOP

  IOP will be measured in both eyes, after induction of anesthesia and before the onset of surgery

  first hour of anesthesia

Study Arms (3)

concentration profile 1

ACTIVE COMPARATOR

IOP will be measured under this order of sevoflurane concentrations: 7%, 5%, 2%, 0.5%

Other: concentration profile 1

concentration profile 2

ACTIVE COMPARATOR

IOP will be measured under this order of sevoflurane concentrations: 7%, 2%, 5%, 0.5%

Other: concentration profile 2

concentration profile 3

ACTIVE COMPARATOR

IOP will be measured under this order of sevoflurane concentrations: 7%, 0.5%, 5%, 2%

Other: concentration profile 3

Interventions

concentration profile 1 OTHER

IOP will be measured under this order of sevoflurane concentrations: 7%, 5%, 2%, 0.5%

Also known as: IOP measurements 1

concentration profile 1

concentration profile 2 OTHER

IOP will be measured under this order of sevoflurane concentrations: 7%, 2%, 5%, 0.5%

Also known as: IOP measurements 2

concentration profile 2

concentration profile 3 OTHER

IOP will be measured under this order of sevoflurane concentrations: 7%, 0.5%, 5%, 2%

Also known as: IOP measurements 3

concentration profile 3

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children with healthy eyes, undergoing elective surgery for strabismus correction or tear duct probing and irrigation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

• Artru AA, Momota Y. Trabecular outflow facility and formation rate of aqueous humor during anesthesia with sevoflurane-nitrous oxide or sevoflurane-remifentanil in rabbits. Anesth Analg. 1999 Apr;88(4):781-6. doi: 10.1097/00000539-199904000-00019.

  PMID: 10195524 BACKGROUND

Study Officials

• Idit Matot, MD

  Tel-Aviv Sourasky Medical Center

  STUDY CHAIR

Central Study Contacts

Idit Matot, MD

CONTACT

97236974758; iditm@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 25, 2010
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 25, 2010

Record last verified: 2010-11

Locations

IL (1)