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临床试验/NCT05221151
NCT05221151已完成4 期

Efficacy of Preoperative Melatonin Versus Pregabalin on Intraoperative Anxiolysis and Sedation During Hip Arthroplasty Under Regional Anesthesia

Menoufia University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年1月30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
已完成
入组人数
78
试验地点
1
主要终点
Ramsey Sedation scale

研究概览

简要总结

preoperative melatonin, pregabalin or both will be given to all patients preoperative

详细描述

On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Sedation score (ramsay sedation score)(10) will be recorded on arrival to OR An 18-gauge cannula will be inserted in a peripheral vein and a warmed (37°C) lactated Ringer solution infusion was started. Ondansetron 4 mg will be administered intravenously as a prophylaxis against nausea and vomiting. Thereafter the patient will be supported in the sitting position. Intrathecal anaesthetic (room temperature hyperbaric bupivacaine 0.5% (20 mg) + fentanyl 25 μg (0.5 mL) will be given under complete aseptic technique . The patient was returned to the supine position for 15 min then to lateral position with operative side up.

HR and blood pressure will be measured every 2.5 minutes intraoperatively, however, the values will be recorded in the anesthesia chart only every five minutes for 2 hours then every 15 minutes for 3 hours. Durations will be calculated considering the time of spinal injection as time zero.

Hypotension (SAP<100 mmHg or <80% of the baseline measured before spinal anaesthesia) will be treated by ephedrine 6 mg, to be repeated if inadequate response within 2 minutes. If bradycardia (HR≤60 bpm) developed, atropine (0.6 mg) will be given to restore adequate HR (≥60 bpm).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I or II
  • patients undergoing hip arthroplasty
  • patient consent for spinal anaesthesia
  • patient alert, concious and good mental condition

排除标准

  • Patients with any neurolgical or psychiatric history before the procedure
  • Patients with a history of chronic pain
  • patients with known allergy to any of this study drugs
  • patients have Any contraindication to neuraxial block.

研究组 & 干预措施

melatonin

Active Comparator

26 patients will receive melatonin 10 mg

干预措施: Melatonin (Drug)

melatonin

Active Comparator

26 patients will receive melatonin 10 mg

干预措施: Ondansetron 4 MG (Drug)

pregabalin

Active Comparator

26 patients will receive pregabalin 150 mg

干预措施: Pregabalin (Drug)

pregabalin

Active Comparator

26 patients will receive pregabalin 150 mg

干预措施: Ondansetron 4 MG (Drug)

melatonin and pregabalin

Active Comparator

26 patients will receive melatonin 5 mg plus pregabalin 75 mg

干预措施: Melatonin (Drug)

melatonin and pregabalin

Active Comparator

26 patients will receive melatonin 5 mg plus pregabalin 75 mg

干预措施: Pregabalin (Drug)

melatonin and pregabalin

Active Comparator

26 patients will receive melatonin 5 mg plus pregabalin 75 mg

干预措施: Ondansetron 4 MG (Drug)

结局指标

主要结局

Ramsey Sedation scale

时间窗: on arrival to operating room then every 6 hours untill 48 hours

change of sedation of the patient on a scale from the night before surgery

VAS

时间窗: on arrival to operating room then every 6 hours untill 48 hours

change of VAS of the patient on a scale from the night before surgery

次要结局

未报告次要终点

研究者

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

mostafa saieed fahim mansour

lecturer

Menoufia University

研究点 (1)

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