A Comparative Evaluation of Nebulized Dexmedetomidine and Nebulized Ketamine as a Premedication in Pediatric Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- the sedating effects of these drugs .
研究概览
简要总结
preoperative anxiety and parental deprivation can be a traumatic time for young children undergoing surgery and remain challenges to anesthesiologists. Preoperative anxiety stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood pressure, and cardiac excitability. Pediatric anesthesiologists strive to minimize distress for children in the operating room (OR) environment and to provide a smooth induction of anesthesia
详细描述
This prospective double-blind randomized controlled study will be carried out in Tanta University Hospitals in Anesthesia Department from July 2021 to december 2021 on pediatric patients undergoing surgeries.
A written informed consent will be obtained from all patient parents who will receive an explanation to the purpose of the study and will have a secret code number to ensure privacy to participants and confidentiality of data.
Research results will be only used for scientific purposes. Procedures will be approved by both the Institutional and the Regional ethical committees.
Any unexpected risk appears during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken to overcome or minimize these risks.
Randomization will be performed using the sealed opaque envelope technique; each patient's parent randomly selected a sealed envelope containing a group number in which the patient will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The children included in this study:
- •Will be of either gender.
- •Age between 3 and 10 years.
- •Belonging to American Society of Anesthesiologists (ASA) I, II physical status.
- •Undergoing elective surgery ranging in time between 30 - 90 minutes under general anesthesia.
排除标准
- •Parental refusal of participation.
- •Chest infection or respiratory distress.
- •Cardiac disease.
- •Mental or physical disability.
- •Treatment with sedatives or anticonvulsants.
- •Allergy to drugs or their ingredients.
研究组 & 干预措施
control group 1
control group (nebulized normal saline without drug: group C) .The drugs will be prepared in 0.9% normal saline to a final volume of 3ml. Nebulization will be performed using a wall nebulizer and wall oxygen source on 4 l/min . A Research nurse who will not participate in the evaluation of sedation administered the drugs to all children in nebulizer sessions ∼30 min before transfer to the OR.
干预措施: normal saline without drug (Other)
dexmedetomidine group 2
that receive nebulized dexmedetomidine (3 μg/kg; group D),The drugs will be prepared in 0.9% normal saline to a final volume of 3ml. Nebulization will be performed using a wall nebulizer and wall oxygen source on 4 l/min . A Research nurse who will not participate in the evaluation of sedation administered the drugs to all children in nebulizer sessions ∼30 min before transfer to the OR.
Patients will be assessed for sedation score then separated from their parents and the ease of separation will be recorded.
干预措施: Dexmedetomidine (Drug)
ketamine group 3
nebulized ketamine (3mg/kg; group K) ,The drugs will be prepared in 0.9% normal saline to a final volume of 3ml. Nebulization will be performed using a wall nebulizer and wall oxygen source on 4 l/min . A Research nurse who will not participate in the evaluation of sedation administered the drugs to all children in nebulizer sessions ∼30 min before transfer to the OR.
Patients will be assessed for sedation score then separated from their parents and the ease of separation will be recorded.
干预措施: Ketamine (Drug)
结局指标
主要结局
the sedating effects of these drugs .
时间窗: 30 minutes
the sedating effects of these drugs using Ramsay sedation scale as a premedications. Our target score (2 or 3 or 4) on the other side score 1 failure of sedation and score 5 or 6 over sedation. Table :Ramsay sedation scale 1. Anxious and agitated, restless, or both. 2. Cooperative, oriented, and calm. 3. Responsive to commands only. 4. Exhibiting brisk response to light glabellar tap or loud auditory stimulus. 5. Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus. 6. Unresponsive.
次要结局
- ease of parental separation(30 minutes)
研究者
alaa abohagar
Alaa Abo Hagar, M.D Lecturer of Anesthesia and Intensive Care,
Tanta University