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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01575626
First received: March 28, 2012
Last updated: April 10, 2012
Last verified: April 2012

March 28, 2012
April 10, 2012
May 2012
May 2013   (final data collection date for primary outcome measure)
effect of different end-tidal sevoflurane concentrations on the IOP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01575626 on ClinicalTrials.gov Archive Site
propofol vs. sevoflurane on IOP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To compare the influence of propofol vs. sevoflurane on IOP
Same as current
Not Provided
Not Provided
 
The Effect of Different Sevoflurane Concentrations on Intraocular Pressure in Patients Undergoing Ocular Surgery Under General Anesthesia
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
IOP Changes Due to Anesthesia (Healthy Patients)
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: first sevoflurane concentration
    patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 0%, 7%, 4%
    Intervention: Drug: Sevoflurane
  • Active Comparator: second sevoflurane concentration
    patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 4%, 7%, 0%
    Intervention: Drug: Sevoflurane
  • Active Comparator: third sevoflurane concentration
    patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 7%, 4%, 0%
    Intervention: Drug: Sevoflurane
  • 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.
    Intervention: Drug: Sevoflurane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
Not Provided
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Nina Gofman, MD 972-527360475 ninagof@gmail.com
Israel
 
NCT01575626
TASMC-12-IM-0011-CTIL
Not Provided
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP