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

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ClinicalTrials.gov Identifier: NCT01575626
Recruitment Status : Unknown
Verified April 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2012
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE March 28, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date April 11, 2012
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
propofol vs. sevoflurane on IOP [ Time Frame: 1 year ]
To compare the influence of propofol vs. sevoflurane on IOP
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Different Sevoflurane Concentrations on Intraocular Pressure in Patients Undergoing Ocular Surgery Under General Anesthesia
Official Title  ICMJE Not Provided
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE IOP Changes Due to Anesthesia (Healthy Patients)
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575626
Other Study ID Numbers  ICMJE TASMC-12-IM-0011-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date April 2012

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