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临床试验/NCT04917029
NCT04917029已完成不适用

The Efficacy of Adding Dexmedetomidine Perineurally to Bupivacaine in Ultrasound Guided Fascia Iliaca Block Versus Intravenously Infused Dexmedetomidine on Hemodynamic Stability Intraoperatively and Postoperative Analgesia Following Hip Arthroscopy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年5月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Effect of dexmedetomidine infusion

研究概览

简要总结

The current study aims to assess effectiveness of dexmedetomidine as adjuvant to general anesthesia on the hemodynamic stability and narcotic consumption intraoperatively and its effect as adjuvant to fascia iliaca compartment block (FICB) with bupivacaine on the postoperative analgesia following hip arthroscopy (decrease the need to narcotics postoperatively avoiding their complications and increasing the success rate of surgery, by enhancing patients to move easier).

详细描述

This study is a randomized controlled trial at Ain Shams university hospital, Cairo, Egypt. The study will include 88 patients (44 patients) in each group planned for undergoing hip arthroscopy under general anesthesia, will be randomly assigned into one of the following two groups using computer generated codes and opaque sealed envelopes:

All patients will range from ASA I or II, planned for elective hip arthroscopy, aging from 18 to 65 years, body weight renge from 70- 80 Kg of both sexes.

Patients will receive 0.03 mg/kg intravenous (IV) midazolam as a preanesthetic medication, and 1 mg Granisetron as a postoperative nausea and vomiting (PONV) prophylaxis after application of routine monitoring (electrocardiogram, non-invasive blood pressure monitoring and oxygen saturation (SPO2)).

A standard anaesthetic technique will be followed. After preoxygenation for three minutes, anaesthesia will be induced with: propofol 2-3 mg/kg, fentanyl 1µg/kg. Atracuirium besilate 0.5 mg/kg will be used to provide muscle relaxation. All patients will be mechanically ventilated with a tidal volume of 8 ml/kg. 1-2 minimum alveolar concentration (MAC) of isoflurane mixed with oxygen (50%) and air (50%) will be used for maintenance of anesthesia.

GROUP A will receive Dexmedetomidine in dose of of 0.5μg/ kg/hour It elicits a biphasic blood pressure response: a short hypertensive phase followed by hypotension. It is expected that the decreased blood pressure and heart rate, will happen with ongoing therapy within 15 minutes, mediated by central α2A-AR, that decrease the release of noradrenaline from the sympathetic nervous system (10) And that is the reason we will start Dexmedetomidine infusion just after intubation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective hip arthroscopy.
  • ASA I and II patients
  • aged 18 to 65 years,
  • 70-80 kg,
  • both sexes.

排除标准

  • Refusal of the patient to receive FICB or to participate in the study,
  • Impaired renal or hepatic functions,
  • Asthmatic patients.
  • Patients with multiple traumas.
  • Obese patients with Body Mass Index >
  • Allergy to study drugs.
  • Patients with local infection.
  • Previous surgery at the injection area.
  • Bleeding disorders.
  • Patients on anticoagulant therapy,
  • Patients with an opioid analgesic prescription within the last 2 h before the operation.
  • Peripheral neuropathy,
  • Mental and or psychiatric disorders.

研究组 & 干预措施

Active:Group A

Active Comparator

Group A: receive 40 ml bupivacaine 0.25% +5 ml placebo in FICB perineurally in generally anaesthetized patients with intravenous infusion of 0.5 µg/kg/h of Dexmedetomidine.

干预措施: Bupivacaine hydrochloride perineurally (Drug)

Active:Group A

Active Comparator

Group A: receive 40 ml bupivacaine 0.25% +5 ml placebo in FICB perineurally in generally anaesthetized patients with intravenous infusion of 0.5 µg/kg/h of Dexmedetomidine.

干预措施: Dexmedetmidine infusion (Drug)

(Group B

Active Comparator

Group B: receive FICB with dexmedetomidine 80µg diluted in 5 ml normal saline and 40 ml bupivacaine 0.25% added perineurally in generally anaesthetized patients without dexmedetomidine infusion.

干预措施: Bupivacaine hydrochloride perineurally (Drug)

(Group B

Active Comparator

Group B: receive FICB with dexmedetomidine 80µg diluted in 5 ml normal saline and 40 ml bupivacaine 0.25% added perineurally in generally anaesthetized patients without dexmedetomidine infusion.

干预措施: Dexmedetomidine perineurally (Drug)

结局指标

主要结局

Effect of dexmedetomidine infusion

时间窗: introperative

incidence of need rescue agents (fentanyl) intraoperatively and the rate change in heart rate ang blood pressure

次要结局

  • Visual Analogue scale (VAS)(24 hours postoperative)

研究者

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

Ismail Mohammed

Lecturer of Anesthesia

Ain Shams University

研究点 (1)

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