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临床试验/CTRI/2020/03/023680
CTRI/2020/03/023680招募中不适用

Double blinded Randomised Comparative Study of the Effect of Single Preoperative dose of IV Dexmedetomidine vs Fentanyl on the Hemodynamic Stress Responses in Peadiatric patients undergoing Adenotonsillectomy Surgery

NOT APPLICABLE1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年2月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
PAIN AND HEMODYNAMIC RESPONSES DURING SURGERY

研究概览

简要总结

In this study we will be giving 2   pain relieving medications namely fentanyl and dexmedetomidine  (medication defined by randomisation) to the  child before the surgery starts in the holding area.  Every child has 50% chance of receiving the drug, depending upon the randomisation. The child will be given a general anaesthesia and will be monitored during the surgery for the effects of these drugs. We will also monitor after the surgery for any restlessness at the end of surgery or later, pain intensity, need for any further drugs to calm the child or pain relief medications.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • AMERICAN SOCIETY OF ANAESTHESIOLOGISTS grades I & II.
  • Aged between 2-10 years of either sex.

排除标准

  • Emergency procedures
  • Anticipated difficult airway
  • Presence of neck mass
  • Unstable cardiopulmonary condition
  • Pre-existing laryngeal or tracheal pathology
  • Contraindication to dexmedetomidine
  • History of any recent LRTI
  • Bleeding diathesis 9.

结局指标

主要结局

PAIN AND HEMODYNAMIC RESPONSES DURING SURGERY

时间窗: EVERY 5MIN PAIN RESPONSES IN THE FORM OF CHANGES IN HEART RATE AND BLOOD PRESSURES DURING SURGERY

次要结局

  • EMERGENCE AGITATION AT THE END OF SURGERY AS PAED SCORE, PAIN SCORES TILL 2HRS AFTER SURGERY AND NEED FOR RESCUE PAIN MEDICATION(EXTUBATION RESPONSE AT THE END OF SURGEY ,PAIN RESPONSE TILL 2HRS AFTER SURGERY, NEED FOR RESCUE PAIN RELIEVING MEDICATIONS TILL 2HRS AFTER SURGERY)

研究者

发起方
NOT APPLICABLE
申办方类型
Other [ACADEMIC STUDY]

研究点 (1)

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