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临床试验/NCT06215833
NCT06215833尚未招募不适用

Comparison of Emergence and Recovery Profile After Total Intravenous Anesthesia ( TIVA ) Vs Inhalational Anesthesia in Opioid Free Pediatric Tonsillectomy

Assiut University0 个研究点目标入组 120 人开始时间: 2024年1月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
physical activity score

研究概览

简要总结

Compare recovery profile from TIVA and that of total inhalational anesthesia in ambulatory pediatric tonsillectomy and which strategy is more safe and less cost and more smooth in pediatric anesthesia.

详细描述

Complications in pediatric anesthesia can happen even in our modern hospitals with the most advanced equipment and skilled anesthesiologists.

Typical complications in pediatric anesthesia are respiratory problems , medication errors , difficulties with intravenous puncture , and pulmonal aspiration. In postoperative setting , nausea and vomiting , pain , emergence delirium can be mentioned as typical complications.

The choice of anesthetic agent and techniques can influence the occurrence of these complications and thus delay in discharge.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • child between 4 to 10 years
  • without co morbidity
  • ASA score 1
  • mallampati score 1 and 2

排除标准

  • child below 4 years and above 10 years
  • child with co morbidity
  • ASA score above 1
  • mallampati score 3 and 4

研究组 & 干预措施

Group ( p )

This group will undergo anesthesia via total intravenous anesthesia using Propofol in induction and maintenance

干预措施: Propofol (Drug)

Group ( s )

This group undergo anesthesia via total inhalational anesthesia using sevoflurane in induction and maintenance

干预措施: Sevoflurane (Drug)

结局指标

主要结局

physical activity score

时间窗: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* Able to move on command =2 * Some weakness in movement = 1 * Unable to voluntarily move = 0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

hemodynamic stability score

时间窗: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* Blood pressure \< 15% of baseline MAP value =2 * Blood pressure 15%-30% of baseline MAP value =1 * Blood pressure \< 30% below baseline MAP value =0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

respiratory stability score

时间窗: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* Able to breathe deeply = 2 * Tachypnea with good coughs =1 * Dyspneic with weak cough = 0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

level of consciousness score

时间窗: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* Awake =2 * Arousal with minimal stimulation =1 * Responsive only to tactile stimulation =0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

post operative pain score

时间窗: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* None or mild = 2 * Moderate to severe pain controlled =1 * Persistent severe pain = 0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

Oxygen saturation score

时间窗: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* Maintain value \> 90% on room air = 2 * Requires supplemental O2 to maintain value \> 90% = 1 * So2 \< 90% with supplemental O2 = 0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

post operative emetic score

时间窗: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* None or mild nausea with no active vomiting = 2 * Transient vomiting =1 * Persistent moderate to severe nausea and vomiting=0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

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

Ahmed Mahmoud Sayed

Principal Investigator

Assiut University

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