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临床试验/NCT06327399
NCT06327399已完成2 期

Effect of Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose on Hemodynamic Changes During Laryngoscopy and Tracheal Intubation in Adults. A Randomized Comparative Study.

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
Mean blood pressure upon laryngoscopy

研究概览

简要总结

Dexmedetomidine bolus dose may provide similar or less hemodynamic changes (less bradycardia and less hypertension) than infusion dose during induction of anaesthesia and tracheal intubation.

详细描述

Preoperative assessment of all patients undergoing elective surgical procedures under general anaesthesia comprises history taking, clinical examination, laboratory testing (complete blood count, kidney function tests, liver function tests), electrocardiogram, and chest X-ray. The study protocol will be explained to the patients, and their consent will be obtained. The patients will be continuously monitored in the operating room for heart rate, blood pressure, and oxygen saturation (baseline values). Then a 20-gauge cannula will be inserted.

Patients will be randomly assigned into two groups: Group A will receive Dexmedetomidine infusion dose of 1 mcg/kg diluted to 100 ml normal saline infused over 10 minutes and Group B will receive Dexmedetomidine bolus dose of 0.3 mcg/kg diluted to 10 mL normal saline administered intravenously over 60 seconds. Then Patients will be induced with propofol 2mg/kg, followed by atracurium 0.5 mg/kg IV. After 3 minutes, tracheal intubation will be performed with an appropriate size of cuffed tracheal tube and connected to end tidal CO2 monitor. After confirmation of bilateral equal air entry, it is connected to mechanical ventilation using isoflurane 1.2% for maintaining anesthesia and keeping end tidal CO2 between 35-40 mmHg, Ringer's solution at a rate 5ml/kg/hour IV will be infused for fluid maintenance. If heart rate falls below 45 bpm, rescue dose (500 mcg) of atropine will be given. If MAP decreases below 50 mmHg, boluses of 10 mg ephedrine will be given, while escalation of MAP will be treated by boluses of 50 mg propofol.

At the end of surgery, the inhaled gas is off and the patient is reversed with neostigmine 0.05mg/kg and atropine 0.01mg/kg, then extubation is done. The two groups will be observed for changes in hemodynamic parameters i.e. heart rate (HR) and mean arterial blood pressure at preinduction period (baseline), after 1 min from dexmeditomedine taking, after induction, at intubation and 1,3,5 and 10 min after intubation. No intervention will be allowed during these 10 minutes and morphine at a dose 0.1mg/kg will be used as analgesia for surgery after 10 minutes.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I and II patients.
  • Mallampati grade I and II.

排除标准

  • Patient refusal.
  • Morbid obesity.
  • Predicted difficult airway/unanticipated difficult intubation or laryngoscopic attempt lasting greater than 15 seconds or two attempts or more.
  • Patients with uncontrolled sepsis.
  • Pregnancy or breast feeding.
  • Patients with renal impairment i.e. SCr ≥ 1.5
  • Any patient on regular intake of beta blockers or calcium channel blockers.
  • CNS disorders.

研究组 & 干预措施

Group A

Active Comparator

patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min.

干预措施: Dexmedetomidine infusion (Drug)

Group A

Active Comparator

patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min.

干预措施: Atropine Sulfate (Drug)

Group B

Active Comparator

patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds.

干预措施: Propofol (Drug)

Group A

Active Comparator

patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min.

干预措施: Propofol (Drug)

Group B

Active Comparator

patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds.

干预措施: Dexmedetomidine bolus (Drug)

Group A

Active Comparator

patients will receive Dexmedetomidine infusion dose of 1 mcg/kg over 10 min.

干预措施: Ephedrine (Drug)

Group B

Active Comparator

patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds.

干预措施: Atropine Sulfate (Drug)

Group B

Active Comparator

patients will receive Dexmedetomidine bolus dose of 0.3 mcg/kg over 60 seconds.

干预措施: Ephedrine (Drug)

结局指标

主要结局

Mean blood pressure upon laryngoscopy

时间窗: 1 minute

mean blood pressure measurement (mmhg) during laryngoscopy

次要结局

  • Blood pressure & Heart rate(1 min after dexmeditomedine, after induction, at intubation and 1,3,5 and 10 min after intubation)
  • Propfol(induction)
  • Bradycardia(from start of dexmedetomidine injection before induction till 10 minutes after intubation)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

maged gamal

Anesthesia lecturer

Kasr El Aini Hospital

研究点 (2)

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