The Effect of Different Sevoflurane Concentrations on Intraocular Pressure in Patients Undergoing Ocular Surgery Under General Anesthesia

NCT01575626 | Unknown

• 1 other identifier: TASMC-12-IM-0011-CTIL
• Study Type: interventional
• Target: 30
• 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. There is an ongoing debate over the effect of anesthetic agents on the IOP. Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic agents, such as propofol and sevoflurane, usually combined with short-acting analgesics, such as remifentanil. Both propofol and sevoflurane are known to reduce the IOP. To this end there is no data in the literature to support or disprove this finding. Study Hypothesis Variations in the end-tidal sevoflurane concentrations have no significant effect on the IOP.

Conditions

IOP Changes Due to Anesthesia (Healthy Patients)

Outcome Measures

Primary Outcomes (1)

• effect of different end-tidal sevoflurane concentrations on the IOP

  To assess the effect of different end-tidal sevoflurane concentrations on the IOP in patients undergoing extraocular procedures, i.e. strabismus correction and tear duct probing and irrigation under general anesthesia.

  1 year

Secondary Outcomes (1)

• propofol vs. sevoflurane on IOP

  1 year

Study Arms (4)

first sevoflurane concentration

ACTIVE COMPARATOR

patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 0%, 7%, 4%

Drug: Sevoflurane

second sevoflurane concentration

ACTIVE COMPARATOR

patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 4%, 7%, 0%

Drug: Sevoflurane

third sevoflurane concentration

ACTIVE COMPARATOR

patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 7%, 4%, 0%

Drug: Sevoflurane

Propofol

ACTIVE COMPARATOR

General anesthesia will be induced using propofol (5 mcg/ml) administered by target controlled infusion (TCI - Schnider model).Following tracheal intubation, concentration of propofol will be decreased till 0.

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

All active comparators of this study have the same intervention as mentioned ahead: First IOP measurement will be performed just before anesthesia induction. Standard general anesthesia will be induced using propofol (5 mcg/ml) administered by target controlled infusion (TCI - Schnider model),fentanyl and rocuronium according to standard protocol of general anesthesia. The second IOP measurement will be performed just before tracheal intubation. Following tracheal intubation, concentration of propofol will be decreased till 0 and anesthesia with sevoflurane will be started, followed by 3 more IOP measurements for different end-tidal sevoflurane concentrations (Consented patients will be randomly allocated to one of three groups as mentioned). Total of 5 IOP measurements. IOP will be measured by the ophthalmologist via both TonoPen XL and Schioz devices.

Propofol; first sevoflurane concentration; second sevoflurane concentration; third sevoflurane concentration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will include both men and women over 18 years old undergoing elective surgery for strabismus correction or tear duct probing and irrigation under general anesthesia.

You may not qualify if:

• Patients with known allergies,
• adverse reaction or contraindication (of any other reason) to sevoflurane or remifentanil, or any other anesthetic drug,
• 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

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Central Study Contacts

Nina Gofman, MD

CONTACT

972-527360475; ninagof@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 11, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Last Updated: April 11, 2012

Record last verified: 2012-04

Locations

IL (1)