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临床试验/NCT01958138
NCT01958138已完成2 期

Isoflurane Versus Combination Of Propofol With Isoflurane For Removal Of Laryngeal Mask Airway In Children

Aga Khan University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Emergence time duration

研究概览

简要总结

The study will be done in paediatric patients by comparing two different techniques of Laryngeal Mask Airway (LMA) removal under deep anesthetic plane.

The both study techniques will be compared for safe LMA removal on the basis of adverse airway events and emergence time duration and recovery room stay timing.

详细描述

  • Study will be start after confirming the approval of institutional ethical review committee and after fulfilling the study inclusion criteria. The detailed study protocol will be explain to the parent/guardian and written & informed consent will be taking on his/her will.

  • Inclusion Criteria

  • Age between 2 to 10 years,

  • American Society of Anaesthesiologists (ASA) physical status I & II,

  • Patient is not contraindicated to Laryngeal Mask Airway insertion,

  • Elective below umbilical general surgical procedures

  • patient is planned for general anesthesia with spontaneous breathing.

  • Fifty patients will participate in both study groups.

  • All patients will be premedicated with oral midazolam 0.3mg/kg, 45 to 60 minutes prior to induction.

  • After arrival of patients in operating room, routine anesthesia monitoring will be applied and baseline blood pressure, heart rate, respiratory rate and oxygen saturation will be recorded.

  • Patient will be induced with anesthetic induction inhalational agent (sleeping drug) sevoflurane 8% with oxygen by pediatric anesthesia circle system. The sevoflurane concentration will be adjusted to 3% to 4% once the adequate depth of anesthesia achieved, as evident by jaw relaxation and tolerance of an oral airway.

  • The LMA will be placed after the insertion of intravenous line.

  • The LMA size will be determined as per manufacturer's recommendation; which suggest 1.5 LMA size for 5-10 kg, size 2 for 10-20 kg and size 2.5 for 20-30 kg.

  • The anesthesia will be maintained with isoflurane in 60% nitrous oxide and 40% oxygen. Patients will be ventilated by spontaneous mode by 'Mapleson F anesthesia circuit' and for above 25 Kg patient, the circle system will be used.

  • Caudal analgesia was standardised in both study groups.

  • Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I.

The group-II LMA will removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen. In both groups; LMA will be removed with inflated cuff, throat was suctioned and patients were turned into lateral recovery position.

Isoflurane and nitrous oxide were turned off and 100% oxygen supplemented till the patient had regained consciousness. All participants were transported to Post Anesthesia Care Unit (PACU) once ensured airway patency and peripheral oxygen saturation (Sp02) greater than 93% on room air. Children were allowed to wake up effortlessly in PACU at oxygen 5 litters/minutes via Hudson mask.

  • The following study variables will be recorded;

研究设计

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

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist class-I & II patients.
  • mallampatis class I & II.
  • Age from 2 years to 10 years.
  • Elective surgical patients for below umbilical general surgical procedures.

排除标准

  • Congenital disorders
  • Airway or facial abnormalities
  • Reactive airway disease/asthma
  • Anticipated difficult airway
  • History of Upper respiratory tract infection in last 3 weeks
  • History of gastroesophageal reflux disorders
  • Known allergic to isoflurane and propofol

研究组 & 干预措施

propofol with Isoflurane

Experimental

Propofol with Isoflurane, Group-I is the intervention arm with combination of two drugs such as low dose propofol and Isoflurane MAC awake.

干预措施: comparison of group-I (low dose propofol with isoflurane) (Drug)

alone isoflurane

Active Comparator

The group-II is the control arm of study by using the only Isoflurane 1.2 MAC

干预措施: comparison of group-I (low dose propofol with isoflurane) (Drug)

结局指标

主要结局

Emergence time duration

时间窗: 15 minutes of continuous monitoring and time frame was started from the LMA removal

Impact on emergence time duration because of intervention such as delayed awakening or responding

Emergence airway complications

时间窗: 15 minutes of continuous monitoring and time frame was started from the LMA removal

Smooth LMA removal will be assessed by adverse airway events like; coughing, bucking, hypersalivation, O2 desaturation (Sp02\<90%), airway obstruction (noisy or stridor breathing) requiring jaw support, laryngospasm, bronchospasm, retching and vomiting, time duration from LMA removal up to 15 minutes.

Post anaesthesia care unit stay time duration

时间窗: 0-45 minutes of continuous monitoring and time frame was started from the PACU admission to discharge

Impact of intervention on post anaesthesia care unit admission to discharge time duration

次要结局

未报告次要终点

研究者

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

Dileep Kumar

Assistant Professor

Aga Khan University

研究点 (1)

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