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临床试验/NCT04659642
NCT04659642Unknown早期 1 期

Attenuation of Airway and Cardiovascular Responses to Extubation in Chronic Smokers by Prior Treatment With Dexmedetomidine, Fentanyl and Their Combination

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
66
试验地点
1
主要终点
post extubation laryngospasm, bronchospasm or desaturation

研究概览

简要总结

The aim of this blind comparative study was to compare the effects of dexmedetomidine, fentanyl and their combination on airway reflexes and hemodynamic responses to tracheal extubation in Adult chronic male smoking patients scheduled for abdominal surgeries (of average 2-3 hours duration).

详细描述

Tracheal extubation is associated with acute, transient, significant and undesirable hemodynamic and airway responses that may persist into the recovery period. Respiratory complications after tracheal extubation are three times more common than complications occurring during tracheal intubation and induction of anesthesia (4.6% vs 12.6%) .

The peak changes are noticed about 1 minute following extubation and may continue until 10 minutes . The reflexes ranges from coughing, bucking, agitation to bronchospasm, laryngospasm, laryngeal oedema, negative pressure pulmonary oedema, tachycardia, hypertension, arrhythmias, left ventricular failure, myocardial ischemia, increased bleeding, raised intracranial and intraocular pressure and cerebrovascular hemorrhage in susceptible individuals. Although most patients can tolerate these transient effects without any significant consequences, but this could be detrimental in patients operated for cardiac, neuro or ophthalmic lesions especially if hypertensive or diabetic. However, Tracheal extubation in smokers will increase difficulty.

Smoking is a risk factor for intraoperative and postoperative complications mainly related to pulmonary and cardiovascular systems. Long-term exposure to cigarettes causes an increased response to the mechanical stimulation caused by extubation.

Smoking affects oxygen transport and delivery , Irritants in smoke increase mucous secretion which becomes hyper viscous with impaired tracheobronchial clearance . Smoking increases sympathetic activation due to increased release of catecholamines and the delay in nicotine clearance from the neuroeffector junction leading to higher blood pressure, tachycardia, and increase peripheral vascular resistance .

For a smooth extubation, there should be no straining, movement, coughing, breath holding or laryngospasm. Extubation at light levels of anesthesia or sedation can stimulate reflex responses via tracheal and laryngeal irritation . A variety of drugs such as esmolol, alfentanil, diltiazem, verapamil, fentanyl, and lidocaine have been used to control hemodynamic changes and upper airway tract events, but they all have limitations and side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Chronic cigarette smokers (patients have smoked for two years at least, and a minimum consumption of 10 cigarettes/ day)
  • American Society of Anesthesiologists (ASA) II.
  • Normotensive and receiving no medications
  • Body mass index of 30 kg/m2
  • Mallampati classification I-II

排除标准

  • History of opioid, sedative drugs or medications affecting heart rate or blood pressure.
  • Morbid obesity.
  • Current upper respiratory infection
  • Hypovolemia
  • History of sleep apnea or Difficult Intubation.
  • Emergency procedures.
  • Hepatic or renal impairment.
  • Drug allergy to Dexmeditomidine or fentanyl.

研究组 & 干预措施

dexmedetomidine group (group A)

Active Comparator

will receive Dexmedetomidine 1ug/kg body weight IV diluted to 100ml normal saline (NS) over 15 minutes.

干预措施: Dexmedetomidine Injection [Precedex] (Drug)

Fentanyl group (group B)

Active Comparator

will receive Fentanyl 1 ug/kg body weight IV diluted to 100 ml normal saline (NS) over 15 minutes.

干预措施: Fentanyl Citrate Injection (Drug)

Both Dexmedetomidine and fentanyl group (group C)

Active Comparator

will receive both Dexmedetomidine 1ug/kg body weight mixed with fentanyl 1ug/kg in 100 ml normal saline (NS) over 15 minutes.

干预措施: dexmedetomidine and fentanyl (Combination Product)

结局指标

主要结局

post extubation laryngospasm, bronchospasm or desaturation

时间窗: 30 minutes

laryngospasm, bronchospasm or desaturation

Quality of extubation by extubation quality score

时间窗: 5 minutes

1. No coughing 2. Smooth extubation, minimal coughing (1 or 2 times) 3. Moderate coughing (3 or 4 times) 4. Severe coughing (5-10 times) and straining 5. Poor extubation, very uncomfortable (laryngospasm and coughing \>10 times).

次要结局

  • Hemodynamic responses(up to 60 minutes)
  • Time to extubation(up to 25 minutes)
  • • Postoperative agitation and sedation were evaluated on a 10 points scale (RASS Scale)(up to 30 minutes)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Fahmy Mohamed Abdelwahab

Doctor

National Cancer Institute, Egypt

研究点 (1)

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