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临床试验/ACTRN12621001289808
ACTRN12621001289808已完成4 期

Comparison of the anesthetic effect of different dosages of tetracaine 0.5% ophthalmic solution on corneal sensation in healthy adults

niversidad Autónoma de Yucatán0 个研究点目标入组 81 人开始时间: 2021年9月23日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
81

研究概览

简要总结

  1. Research question. What is the effect of different dosages of tetracaine 0.5% ophthalmic solution on corneal sensation? 2. Background information. Tetracaine hydrochloride ophthalmic solution is a long action aminoesther local anesthetic. It is used widely on ophthalmology at a 0.5% solution. The recomended dosage depends on the manufacturer and goes from a single drop to 5 drops applied at 5 minutes intervals, and there are trials assessing the security and efficacy on different settings. Nevertheless, we did not find any trial comparing the efficacy of different dosages on humans. 3. Participants characteristics. Healthy subjects 18 years old or older. 4. Key results. The Duration of the maximal anesthetic effect was longer when tetracaine was applied at a greater dosage. The duration of corneal anesthesia was similar in the three groups. The degree of the maximal anesthetic effect was greater with a greater dosage. Baseline corneal sensation was similar in males and females. There were no severe adverse events derived from the use of Cochet-Bonnet or tetracaine. Limitations. 5. Limitations. Balanced salt solution as placebo does not cause a burning sensation like tetracaine, thus probably affecting the blinding. Cochet Bonnet anesthesiometer measures superficial touch sensitivity, and the results may vary when transposed to a surgical setting. We did not measure sensation beyond 63 minutes, affecting the results regarding the duration of corneal anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Healthy subjects.
  • 18 years old or older.

排除标准

  • Any known systemic disease.
  • Any known ophthalmic disease.
  • Contact lens wear.
  • Previous ophthalmic surgery.
  • The presence of symptoms or signs of any ophthalmic disease.

研究者

发起方
niversidad Autónoma de Yucatán

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