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

April 10, 2012 updated by: Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: first sevoflurane concentration
patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 0%, 7%, 4%
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.
Active Comparator: second sevoflurane concentration
patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 4%, 7%, 0%
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.
Active Comparator: third sevoflurane concentration
patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 7%, 4%, 0%
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.
Active Comparator: Propofol
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of different end-tidal sevoflurane concentrations on the IOP
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
propofol vs. sevoflurane on IOP
Time Frame: 1 year
To compare the influence of propofol vs. sevoflurane on IOP
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimate)

April 11, 2012

Study Record Updates

Last Update Posted (Estimate)

April 11, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-12-IM-0011-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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