Intranasal Dexmedetomidine Versus Intranasal Ketamine for Preoperative Sedation in Pediatrics
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Sedation score as assessed by MOAA/S
研究概览
简要总结
This study aims to compare intranasal dexmedetomidine versus intranasal ketamine as a premedication in children undergoing surgery in our population. Hypothesis is Intranal dexmedetomidine is better than intranasal ketamine in producing preoperative sedation in pediatric patients undergoing surgery under general anesthesia.
详细描述
This is a prospective, randomized, double-blind, controlled trial with Minimum 6 months of data collection. Patients will be randomly divided into 2 groups; Group D and Group K with 30 patients in each group. Group D will receive dexmedetomidine 2 mcg/kg intranasal, diluted in normal saline to a total volume of 1 mL and will be administered 0.5 mL per nostril while group K will receive ketamine 2mg/kg intranasal, diluted in normal saline to a total volume of 1 mL similarly divided into two nostrils. The study drugs will be prepared by a second anesthesiologist who will not be involved in subsequent assessments. The calculated dose for each patient will be administered 30 minutes before induction of anesthesia in preoperative holding area in parental/guardian presence. Sedation level will be assessed at 10 minutes interval for the next 30 minutes or until the child will be shifted to the operating room using MOAA/S and ease of parental separation will be scored using PSAS. All patients will be monitored using standard ASA monitoring (ECG, non-invasive blood pressure , pulse oximetry) before induction then every 5 minutes till the end of surgery or a maximum of 1 hour in the operating room. All patients will be induced with 6-8% sevoflurane in 100% oxygen and a 24-G IV access will be secured once the child is asleep. Nalbuphine 0.1 mg/kg IV, atracurium 0.5mg/kg IV (or rocuronium 0.6mg/kg if there's contraindication to atracurium). After endotracheal intubation or laryngeal mask airway (LMA) insertion, all patients will be maintained with 50% O2 in air with isoflurane. Ventilation will be adjusted to maintain an end tidal CO2 concentration between 30-40mmHg. All patients will be given IV paracetamol 20mg/kg as part of multimodal analgesia. If heart rate drops <70 bpm, atropine 10mcg/kg I/V will be used and hypotension will be treated with IV adrenaline 10mcg/kg. Neuromuscular blockade will be reversed with 50mcg/kg neostigmine and 10mcg/kg glycopyrolate. After regaining regular and spontaneous breathing, the endotracheal tube or LMA will be removed and the child will be shifted to post-anesthesia care unit (PACU).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of Anesthesiologist (ASA) class-I and II
- •Children 2-6 years of age undergoing elective surgery
排除标准
- •Known hypersensitivity to study drugs
- •Refusal of consent
- •Known renal, hepatic or cardiac dysfunction
- •Nasal deformity or pathology
- •Recent upper respiratory infection (within 2 weeks)
- •Children undergoing neurosurgery or ophthalmic surgery
研究组 & 干预措施
Intranasal Dexmedetomidine
Received Intranasal Dexmedetomidine
干预措施: Intranasal dexmedetomidine (Drug)
Intranasal ketamine
Received Intranasal Ketamine.
干预措施: Intranasal ketamine (Drug)
结局指标
主要结局
Sedation score as assessed by MOAA/S
时间窗: 6 months
Modified Observer's Assessment of Alertness/ Sedation scale (MOAA/S): 6 = Appears alert and awake, responds readily to name spoken in a normal tone 5 = Appears asleep but responds readily to name spoken in a normal tone 4 = Lethargic response to name spoken in a normal tone 3 = Responds only after the name is called loudly or repeatedly 2 = Responds only after mild prodding or shaking 1 = Does not respond to mild prodding or shaking
次要结局
- Ease of parental separation using PSAS(6 months)
- Incidence of hypotension and bradycardia in the two groups(6 months)
研究者
Aimon Irshad
Principal Investigator
Liaquat National Hospital & Medical College
