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临床试验/NCT04365686
NCT04365686已完成4 期

Reliable and Rapid Smooth Extubation After Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary: A Randomized Controlled Trial.

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2019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
4 期
状态
已完成
入组人数
106
试验地点
1
主要终点
smoothness of extubation

研究概览

简要总结

the effect of ketofol, a combination of propofol and ketamine, on hemodynamics and airway response during induction of general anesthesia has been studied before. Its effect on the smoothness of extubation has not been studied before. In the present study; we aimed to assess the effect of ketofol on the smoothness of extubation as regards, airway response, sedation score during suction and extubation and hemodynamic changes comparing it with propofol for induction of general anesthesia.

详细描述

After securing intravenous access by a 20g catheter, intravenous premedication (midazolam 2 mg and 4mg ondansetron) was administered to all patients. Standard ASA(american society of anesthesiologists) monitoring (5-lead ECG, noninvasive blood pressure (NIBP), and pulse oximetry) was applied to all the patients for the recording of heart rate (HR), NIBP and oxygen saturation by a multiparameter monitor. Induction of general anesthesia was achieved as follows: in Group K (Ketofol group), fifty three female patients received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia while in Group P (Propofol group), fifty three female patients received propofol (2mg/kg) only at the induction of general anesthesia.

Patients in both groups received fentanyl 2 ug\kg and atracurium 0.5 mg\kg. After tracheal intubation, general anesthesia maintained by isoflurane 1.5 volume % in 2 L\min oxygen-air mixture 50:50 and atracurium 0.1 mg\kg every 30 minutes, if needed. At the end of the surgery, inhalational anesthesia was stopped and reversal of the patients was done by injection of neostigmine 0.05mg\ kg and atropine 0.01mg\kg.

Hemodynamics (HR and mean arterial pressure ''MAP'') was assessed at 5 minutes interval from the time of reversal of muscle relaxant up to 30 minutes after extubation.

The level of sedation during suction and extubation was assessed using observer assessment sedation score and the airway response under direct laryngoscopy to suction was noted by five-point scale. After 5 minute interval, the level of sedation and smoothness of extubation was noted by four-point scale.

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • American Society of Anesthesiologists Physical status ''ASA PS'' class I and II scheduled for laparoscopic drilling for polycystic ovary under general anesthesia.

排除标准

  • from cardiac, hepatic, renal diseases, history of epilepsy
  • Patient refusal.
  • known drug allergy.

研究组 & 干预措施

Group K

Active Comparator

Ketofol group

干预措施: Ketofol as induction agent (Drug)

Group P

Active Comparator

propofol group

干预措施: Propofol as induction agent (Drug)

结局指标

主要结局

smoothness of extubation

时间窗: 5 minutes after extubation

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

次要结局

  • Age(6 hours before intervention)
  • weight(6 hours before intervention)
  • Height(6 hours before intervention)
  • BMI(6 hours before intervention)
  • mean arterial pressure (MAP)(20 minutes after extubation)
  • heart rate (HR)(20 minutes after extubation)
  • airway response to laryngoscopy and suction(5 minutes after extubation)
  • sedation score(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

Lecturer

Fayoum University Hospital

研究点 (1)

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