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

IOP Changes Due to Anesthesia (Healthy Patients) Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01575626
• Other study ID #: TASMC-12-IM-0011-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 28, 2012
• Last updated: April 10, 2012
• Start date: May 2012

Study information

• Verified date: April 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nina Gofman, MD
• Phone: 972-527360475
• Email: ninagof[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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. Previous studies have compared these two anesthetics protocols in order to determine which provides superior control of the IOP. Propofol produced significantly lower IOP measurements compared to sevoflurane (both combined with remifentanil), in cataract surgery, whereas in non-ophthalmic surgery propofol and sevoflurane caused a comparable decrease in IOP. Sevoflurane, an inhalational anesthetic, has a rapid onset of action faster recovery time and is also suitable for inhalation induction because it does not irritate the airway. A prospective randomized clinical trial compared the effects of ketamine and sevoflurane on IOP during the eight minutes after induction of anesthesia (in 2-minute intervals) in children with suspected or diagnosed glaucoma undergoing EUA. During these 8 minutes the IOP decreased significantly only in the sevoflurane group. This finding contradicted claims that measurements immediately after induction are relatively unaffected by anesthetics and suggested that variations in sevoflurane concentration do affect the IOP. Yoshitake et al showed that the remarkable reductions of IOP after inductions are probably caused by induction agents, suggesting that sevoflurane is a useful anesthetic for elderly patients receiving ophthalmic surgeries. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• IOP Changes Due to Anesthesia (Healthy Patients)

Intervention

Drug:
• Sevoflurane
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.

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	propofol vs. sevoflurane on IOP	To compare the influence of propofol vs. sevoflurane on IOP	1 year	No