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临床试验/NCT05513209
NCT05513209已完成不适用

Comparative Study Between Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations

Ain Shams University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
postoperative VAS score

研究概览

简要总结

intraoperative opioid administration versus intraoperative pterygopalatine ganglion block based opioid free anesthesia to compare outcomes such as postoperative administration of opioid rates of nausea and vomiting, Post Anesthesia Care Unit (PACU) length of stay

详细描述

Group A ;( opioid based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.

Group B ;( opioid free pterygopalatine ganglion block based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.

For each patient, intraoperative hemodynamics, additional intraoperative analgesia required, the length of PACU stay, administration of postoperative opioids, administration of postoperative non-opioid analgesics, postoperative (visual analogue score) VAS score, will be recorded.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 13 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age 4 to 13 years old.
  • •Elective tonsillectomy or adenotonsillectomy surgery

排除标准

  • •Allergies to xylocaine.
  • •Developmental delays.
  • •Significant cognitive impairment.
  • •American Society of Anesthesiologists (ASA) Class 3 and
  • •Patients who underwent any additional concurrent procedures such as lingual tonsillectomy.

研究组 & 干预措施

opioid based multimodal anesthesia

Active Comparator

One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.

干预措施: opioid based multimodal anesthesia (Procedure)

opioid free pterygopalatine ganglion block based multimodal anesthesia

Active Comparator

One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.

干预措施: pterygopalatine ganglion block based multimodal anesthesia) (Procedure)

结局指标

主要结局

postoperative VAS score

时间窗: EVERY HOUR AFTER SURGERY FOR 24 HOURS

次要结局

  • TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS(DURING SURGERY)
  • INTRAOPERATIVE HEART RATE(EVERY 10 MINUTES up to 1 hour)
  • INTRAOPERATIVE BLOOD PRESSURE(EVERY 10 MINUTES up to 1 hour)
  • TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY(24 HOURS AFTER SURGERY)
  • length of PACU stay(one day after operation)

研究者

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

RAMY AHMED

Assistant Professor of Anesthesia

Ain Shams University

研究点 (1)

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