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
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)
