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临床试验/NCT06369103
NCT06369103招募中4 期

Comparison of the Sedative Effects of Dexmedetomidine and Propofol During Peribulbar Anaesthesia in Patients Undergoing Vitrectomy Surgery: A Prospective Randomized Clinical Trial

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
420
试验地点
1
主要终点
Patient satisfaction

研究概览

简要总结

The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events.

详细描述

In ocular surgery, local anesthesia or regional anesthesia is generally preferred over general anesthesia because of quicker patient rehabilitation and the avoidance of possible complications from general anesthesia. However, even with these anesthesia techniques, pain, fear and anxiety are major predictors of lower patient satisfaction.

Vitrectomy surgery is one of the most common outpatient ophthalmic surgeries. It can be performed with peribulbar anesthesia and intravenous (IV) sedation support, allowing the procedure to be completed in most patients without the need for general anesthesia. Vitrectomy surgery is a painful and lengthy procedure; therefore, sedation is applied to reduce patient agitation, ensuring both surgical comfort and hemodynamic stability. However, various complications can arise during the perioperative period depending on the sedation agent used.

Intravenous sedation is frequently used during ophthalmic regional anesthesia. There is no 'ideal' drug for sedation or analgesia. Various drugs either alone or in combination have been used with different methods of administration. The preferred sedative agent for ophthalmic surgeries performed under local anesthesia should have rapid onset but a short duration of action to ensure rapid recovery. It should be non-accumulating, non-toxic and have a favorable therapeutic index with minimal side effects. Unfortunately no drug is presently available that fulfils all these criteria. The available sedative drugs are benzodiazepines, intravenous anaesthetic induction agents (e.g. propofol), opiates and α-adrenoreceptor agonists such as dexmedetomidine or clonidine.

Among anesthetic agents, Dexmedetomidine is a strong selective α2-adrenergic agonist with sympatholytic, anxiolytic, analgesic and dose-dependent sedative/hypnotic properties, without causing respiratory depression.

Moreover, the use of dexmedetomidine reduces anesthetic and opioid requirements and also psychomotor function to be reserved.

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
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20-70 years.
  • Expected time of surgery less than 2 hours

排除标准

  • patients with an initial mini mental state examination (MMSE) score less than 23
  • Patients refusing LA
  • Clotting abnormalities
  • Impaired mental status
  • Allergy to any of the study medications
  • Also, patients were excluded if they had severe cardiac disease, chronic obstructive lung disease, a history of sleep apnea and those who received general anesthesia.

研究组 & 干预措施

Dexmedetomidine Group

Active Comparator

Patients will receive dexmedetomidine at a dose of 0.5-1.0 mcg/kg over 5-10 minutes, then a maintenance infusion rate of 0.2-0.5 mcg/kg/min when the bispectral index (BIS) value is between 70 and 80.

干预措施: Dexmedetomidine (Drug)

Propofol Group

Active Comparator

Patients will receive propofol at a dose of 0.25-0.5 mg/kg over 5-10 minutes, then a maintenance Infusion rate of 0.5-2 mg/kg/hr when the bispectral index (BIS) value is between 70 and 80.

干预措施: Propofol (Drug)

结局指标

主要结局

Patient satisfaction

时间窗: 6 hours after the end of surgery.

Patient satisfaction will be also assessed using 7-point Likert-like verbal rating scale. One means extremely dissatisfied and seven means extremely satisfied.

次要结局

  • Visual analogue scale(6 hours after the end of surgery)

研究者

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

Dina Mahmoud Fakhry

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Beni-Suef University

研究点 (1)

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