跳至主要内容
临床试验/NCT01841866
NCT01841866Unknown不适用

Does Laryngeal Mask Airway Removal During Deep Anesthesia Reduce Postoperative Sore Throat in Children?

Prince of Songkla University2 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2013年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
456
试验地点
2
主要终点
Incidence of Postoperative Sorethroat

研究概览

简要总结

Laryngeal mask airway (LMA) is widely used in children.The appropriate time to remove laryngeal mask airway is still inconclusive.Sore throat is one of common complications after general anesthesia. Sometimes postoperative sore throat affects patients' satisfaction and daily activities. It can be correlated with dysphagia and may limit oral intake especially in children.The incidence of postoperative sore throat after laryngeal mask airway insertion varies from 5.8-34% in adult(13) and 17.5% in pediatric.Somehow, almost the studies of postoperative sore throat after laryngeal mask airway removal were done in awake state. Our study object to test that post operative sore throat after LMA removal in deep anesthetized children is lower than awake children.

详细描述

Patients age between 6-12 years who have ASA physical status I-II and scheduled for elective surgery will be enrolled in this study and randomly assigned into two groups (group A = awake group and group D = deep anesthetized group) by using computer-generated randomization table. The patients who have the following problems: active airway disease, risk of aspiration, intra-peritoneal or airway surgery will be excluded.

At the day of surgery, demographic data will be recorded by nurse anesthetist. Visual analog scale (VAS) will be used as a tool for evaluating preoperative sore throat.

At the operating room, after standard monitoring and pre-oxygenated with 100% oxygen via tight anesthetic face mask for 5 minutes. Propofol (3-5 mg/kg) and fentanyl(1-3 ug/kg) will be used for induction. After the patient is apnea and loss of eyelash reflex, appropriate size of classic LMA ,which is prepared by fully deflated to forms a smooth "spoon-shape" and be lubricated by water based jelly, will be applied with standard LMA insertion technique. Once LMA is in the right position, air will be inflated to the cuff of LMA, for keeping cuff pressure between 40-60 cmH2O. Air, O2 and Sevoflurane ≥ 1minimal alveolar concentration (MAC) will be used to keep the patient anesthetized. Performer of LMA insertion and number of insertion attempts will be recorded.

At the end of surgery, LMA will be removed with the technique which is followed by the group assignment, group D and group A. After that, patient will be transferred to post anesthetic care unit (PACU).

At PACU, After the patient is fully awake, the blind investigator will ask the patient to evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10). Dysphagia (discomfort when swallowing) using dysphagia score (0 = able to eat normal diet / no dysphagia, 1 = able to swallow some solid foods, 2 = able to swallow only semi solid foods, 3 = able to swallow liquids only, 4 = unable to swallow anything / total dysphagia), dysphonia (discomfort when speaking such as hoarseness) using dysphonia score (0 = no hoarseness, 1 = mild/no hoarseness in the time of interview but had it previously, 2 = moderate/only is felt by the patient or their parents, 3 = severe/recognizable in the time of interview) Any adverse events will be evaluated at 1 hour in PACU. Then the evaluation will be repeated by telephoned interview at 24 and 72 hours respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 6-12 years
  • ASA physical status I-II
  • elective surgery

排除标准

  • active airway disease
  • risk for aspiration
  • intraperitoneal or airway surgery

研究组 & 干预措施

deep anesthetic state

Active Comparator

LMA removal

干预措施: LMA removal (Other)

awake

Placebo Comparator

LMA removal

干预措施: LMA removal (Other)

结局指标

主要结局

Incidence of Postoperative Sorethroat

时间窗: upto 72 hr post operative period

Evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10)

次要结局

  • Adverse event: teeth or mucosal trauma(upto 72 hr postoperative period)
  • laryngospasm(Intraoperative and PACU period)
  • Dysphonia(upto 72 hr postoperative period)
  • Dysphagia(upto 72 hr postoperative period)
  • Bronchospasm(Intraoperative and PACU period)
  • Desaturation(Intraoperative and PACU period)
  • Nausea and vomiting(up to 72 hr postoperative period)
  • cough(up to72 hr postoperative period)

研究者

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

Ngamjit Pattaravit

Doctor

Prince of Songkla University

研究点 (2)

Loading locations...

相似试验