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临床试验/NCT04617652
NCT04617652已完成4 期

Efficacy of Magnesium Sulphate on Smoothness of Extubation in Patients Undergoing General Anaesthesia With Endotracheal Intubation: a Randomized Controlled Trial

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8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
已完成
入组人数
60
试验地点
1
主要终点
smoothness of extubation

研究概览

简要总结

Tracheal extubation is a critical event in the anaesthetic management of patients undergoing general anaesthesia with endotracheal intubation for elective procedures. It the state of art to provide suitable conditions for smooth extubation and avoid coughing, bucking, straining and/or laryngospasm. Several methods have been described to provide a smooth extubation, including the use of remifentanil infusion, dexmedetomidine or fentanyl. Because of its anti-inflammatory and analgesic effects and lack of respiratory depressant actions, magnesium sulphate could be an attractive alternative.

详细描述

A written informed consent will be obtained from all the patients. On arrival to the preparation room intravenous cannula will be inserted, no sedation will be given. In the operating theater standard monitors, non-invasive blood pressure, oxygen saturation and electrocardiogram will be applied before induction of anesthesia, capnography after induction of anesthesia and baseline heart rate (HR), mean arterial blood pressure (MAP) and oxygen saturation (SpO2 ) will be recorded.

All patients in both groups will receive standardized anesthetic technique in the form of intravenous (i.v.) propofol 2 mg/kg, i.v. fentanyl 1-2 lg/kg and atracurium 0.5 mg/kg to facilitate endo-tracheal intubation, mechanical ventilation will be adjusted to keep end tidal carbon dioxide (EtCO2) between 30 and 35 mmHg, and all drugs will be based on ideal body weight. Isoflurane 1% in 50% oxygen and air, and 0.15 mg/kg atracurium every 20 min will be given for maintenance of anesthesia. Intraoperative HR, MAP, EtCO2 and SpO2 values will be recorded at 5- minute intervals till the end of operation. HR and MAP will be maintained within ±20% of the baseline values. Hypotension (defined as MAP < 20% of the baseline value) will be treated by a bolus of 200 ml Ringer's solution if not responding increments of 3-9 mg ephedrine will be given. Hypertension (defined as MAP > 20% of the baseline value) and/or tachycardia (defined as HR > 20% of the baseline value) a supplemental dose (25-50 µg) fentanyl will be given or increasing concentration of isoflurane. Bradycardia (HR < 50 beat per minute) persisting for >2 min will be treated with atropine, 0.4 mg i.v. boluses. Intra-operatively i.v. ondansetron, 4 mg (Zofran, GlaxoSmithKline) will be given for prevention of postoperative nausea and vomiting. After induction of anaesthesia patients will be divided into 2 groups: group C (control group) n= 30 patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour. Group M (magnesium group n=30 patients) will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour.

By the end of surgery isoflurane will be discontinued and the residual neuromuscular block will be antagonized with neostigmine 0.05 mg/kg, given with atropine 0.02 mg/kg, the endotracheal tube will be removed after return of spontaneous breathing, and the patient will obey commands in semi-sitting position, then the patient will be transferred to the post-anesthesia care unit (PACU)

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
Double (Participant, Investigator)

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

  • Elective surgeries that need endotracheal intubation.
  • Duration of surgery 1-3 hours

排除标准

  • Refusal of patients.
  • Patients with hypersensitivity to the study drug.
  • Patients with cardiac disorders, bundle branch block, hart block
  • Neuromuscular disease, calcium channel blocker medication or hypermagnesemia

研究组 & 干预措施

Group M

Active Comparator

Magnesium group

干预措施: Magnesium sulfate (Drug)

Group C

Placebo Comparator

Control group

干预措施: Normal saline (Drug)

结局指标

主要结局

smoothness of extubation

时间窗: Procedure (At time of extubation)

Smoothness of extubation Grade 1. No coughing on endotracheal tube 2. Coughing on the tube 3. Vomiting 4. Laryngospasm

次要结局

  • The duration of surgery(5 minutes after extubation)
  • sedation score(1 hour after extubation)
  • heart rate(20 minutes after induction of anathesia)
  • SpO2(20 minutes after induction of anathesia)
  • Mean arterial blood pressure(20 minutes after induction of anathesia)
  • EtCO2(20 minutes after induction of anathesia)
  • The cumulative opioids (morphine) consumption(6 hours after surgery)
  • visual analogue scale (VAS) pain score(6 hours after extubation)
  • Intraoperative fentanyl needed(5 minutes after extubation)

研究者

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

Atef Mohamed Sayed mahmoud

Principal investigator

Fayoum University Hospital

研究点 (1)

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