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临床试验/NCT07671066
NCT07671066已完成不适用

Dexmedetomidine Versus Dexamethasone as an Additive to Local Anesthetic Mixture in Peribulbar Block in Cataract Surgeries

Helwan University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年12月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Time for first request of the rescue analgesia

研究概览

简要总结

This study aimed to compare the effects of dexamethasone and dexmedetomidine when added to a local anesthetic mixture for peribulbar block in patients undergoing elective anterior segment eye surgery.

详细描述

Regional block (especially peribulbar block) is the preferred choice of anesthesia for many ophthalmic surgeries as it has less complications. Peribulbar block with local anesthetics only lead to delayed onset corneal anesthesia and globe akinesia, and frequent need of block supplementation.

Dexmedetomidine is a drug which belongs to alpha 2 adrenergic receptor agonist. It provides several desirable effects, including sedation, anxiolysis, analgesia, and a reduction in intraoperative opioid requirements, when used as an adjuvant to local anesthetics, dexmedetomidine has been shown to prolong the duration of sensory and motor blocks, improve hemodynamic stability, and enhance overall patient satisfaction.

Dexamethasone, a synthetic corticosteroid, the use of dexamethasone as an additive in peribulbar blocks has been shown to improve the quality of anesthesia, reduce the need for supplemental intraoperative analgesics, and decrease postoperative pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • Age: > 18 years old.
  • Sex: Male & Female
  • American Society of Anesthesiologists (ASA) Physical status I -III.
  • Patients undergoing ophthalmic surgery under local anesthesia.

排除标准

  • Patients' refusal.
  • Patients have active ocular infection.
  • Patients have single eyes.
  • Allergy to thesis medications (mainly bupivacaine and lidocaine).
  • Patients cannot lie flat.
  • Patient on anticoagulation.
  • Abnormal coagulation profile in the form of international normalized ratio (INR) ≥1.6

结局指标

主要结局

Time for first request of the rescue analgesia

时间窗: 24 hours postoperatively

Time for first request of the rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.

次要结局

  • Mean arterial blood pressure(12 hours postoperatively)
  • Postoperative opioid consumption(12 hours postoperatively)
  • Degree of patient satisfaction(24 hours postoperatively)
  • Degree of pain(12 hours postoperatively)
  • Heart rate(12 hours postoperatively)
  • Intraocular pressure(10 min after injection of local anesthetics)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sameh Ashraf Mandouh

Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Helwan University, Egypt.

Helwan University

研究点 (1)

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