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临床试验/NCT01575626
NCT01575626Unknown不适用

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

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
effect of different end-tidal sevoflurane concentrations on the IOP

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

first sevoflurane concentration

Active Comparator

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

干预措施: Sevoflurane (Drug)

second sevoflurane concentration

Active Comparator

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

干预措施: Sevoflurane (Drug)

third sevoflurane concentration

Active Comparator

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

干预措施: Sevoflurane (Drug)

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.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

effect of different end-tidal sevoflurane concentrations on the IOP

时间窗: 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.

次要结局

  • propofol vs. sevoflurane on IOP(1 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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