Intranasal versus Intravenous Dexmedetomidine for reducing emergence delirium in paediatric patients undergoing sevoflurane based anaesthesia A comparative double-blinded randomized trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Level of preoperative agitation (As per Aonos 4 point scale)
研究概览
简要总结
Patients scheduled for elective surgery will be enrolled in the study after obtaining written informed consent. Participants will be randomly assigned to one of two groups—Group A (intranasal dexmedetomidine) or Group B (intravenous Dexmedetomidine)—with 50 patients in each group. Randomization will be performed using a computer-generated sequence in a 1:1 ratio, with allocation concealment ensured by sequentially numbered, opaque, sealed envelopes.
· Group A: Patients will receive intranasal dexmedetomidine at a dose of 1 µg/kg 30 minutes before surgery.
· Group B: Patients will receive intravenous dexmedetomidine at a dose of 0.5 µg/kg over 10 minutes post-induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 2 to 8 years.
- •Children with ASA grade I/II.
- •Children undergoing elective pediatric surgery.
- •Patient’s guardians willing to participate in the study.
排除标准
- •1.Patient’s guardians refusal to participate.
- •2.Children with allergy to dexmedetomidine.
- •3.Children with history of URTI.
- •4.Children with history of nasal obstruction.
- •5.Children with history of seizures.
- •6.Children with history of any cardiac problems.
结局指标
主要结局
Level of preoperative agitation (As per Aonos 4 point scale)
时间窗: Level of emergence delirium (As per PAED score): After extubation, leaving the operating room, after 10 minutes in PACU, after 20 minutes in PACU, after 30 minutes in PACU, after 40 minutes in PACU.
1-calm
时间窗: Level of emergence delirium (As per PAED score): After extubation, leaving the operating room, after 10 minutes in PACU, after 20 minutes in PACU, after 30 minutes in PACU, after 40 minutes in PACU.
2-not calm, but could be easily calmed
时间窗: Level of emergence delirium (As per PAED score): After extubation, leaving the operating room, after 10 minutes in PACU, after 20 minutes in PACU, after 30 minutes in PACU, after 40 minutes in PACU.
3- moderately agitated or restless
时间窗: Level of emergence delirium (As per PAED score): After extubation, leaving the operating room, after 10 minutes in PACU, after 20 minutes in PACU, after 30 minutes in PACU, after 40 minutes in PACU.
4- combative, excited, and disoriented.
时间窗: Level of emergence delirium (As per PAED score): After extubation, leaving the operating room, after 10 minutes in PACU, after 20 minutes in PACU, after 30 minutes in PACU, after 40 minutes in PACU.
Intransal dexmedetomidine may be more convenient to use and of similar efficacy as compared to intravenous dexmedetomidine.
时间窗: Level of emergence delirium (As per PAED score): After extubation, leaving the operating room, after 10 minutes in PACU, after 20 minutes in PACU, after 30 minutes in PACU, after 40 minutes in PACU.
次要结局
- Hemodynamic parameters HR, MAP, sPO2, ETCO2 at before injection, after injection, 5 minutes after start of surgery, 10 minutes after start of surgery, 15 minutes after start of surgery, 20 minutes after start of surgery, after extubation, before transferring to recovery, when arriving at the recovery, in 2nd 10 minutes of recovery, in 3rd 10 minutes of recovery.(Frequency of ondansetron prescription.)
研究者
Asad Reza
IGIMS Patna