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临床试验/CTRI/2024/03/063544
CTRI/2024/03/063544尚未招募4 期

Ketamine-Dexmedetomidine Vs Ketamine-Midazolam combination for peri-operative Sedo-analgesia in preschool children undergoing infraumbilical surgeries under caudal anaesthesia - A comparative randomized study

Sardar Patel Medical College Bikaner Rahasthan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To Compare the Perioperative Sedo-Analgesic Efficacy of Intravenous Ketamine-Dexmedetomidine and Ketamine-Midazolam Combination in Paediatric Patients Posted for Infraumbilical Surgeries Under Caudal Epidural Block to-

研究概览

简要总结

Unlike adults, children are more anxious and uncooperative during invasive and painful clinical procedures. Sedation and analgesia are required to keep the child immobile to facilitate painful procedures.

Various Sedo-analgesic drugs such as ketamine, dexmedetomidine, midazolam, and propofol either alone or in combination are commonly used for several painful invasive procedures with variable degrees of success.

Caudal epidural analgesia is one of the most popular and commonly performed regional blocks in pediatric anesthesia.

Caudal blocks combined with periprocedural sedation are an efficient way to offer perioperative analgesia for painful infraumbilical interventions.

They enable not only early ambulation but also perioperative hemodynamic stability and spontaneous breathing in children with cardiopulmonary co-morbidities.

Bupivacaine has been in clinical use for more than 30 yr and is widely used for caudal epidural analgesia in children because of its long duration of action and beneficial ratio of sensory to motor block.

The combination of Dexmedetomidine-Ketamine (DexKet) and Midazolam-Ketamine (MiKe) seems to have favorable characteristics in the pediatric population.

Ketamine is an anesthetic and analgesic agent with a wide range of applications in paediatric anesthesia. Ketamine (KET) is a phencyclidine derivative whose action is due to the central dissociation of the cortex from the limbic system providing both sedative and analgesic properties while preserving upper airway muscular tone and respiratory drive. It has a rapid onset with a short duration of action that induces good analgesia, sedation, and amnesia with a rapid recovery. ketamine‑induced agitation can be overcome by co‑administration of other drugs. Numerous studies have been tried to compare different drugs such as midazolam, dexmedetomidine (Dex), propofol, clonidine, and haloperidol to reduce these adverse responses.

Dexmedetomidine (DEX) is a specific central alpha 2-adrenergic agonist that is associated with sedative and analgesic sparing effects, reduced delirium and agitation, perioperative sympatholytic, cardiovascular stabilizing effect and preservation of respiratory function.

When used together, DEX may prevent tachycardia, hypertension, salivation and emergence phenomena from KET, whereas KET may prevent bradycardia and hypotension which has been reported with DEX. An additional benefit of rapid onset of sedation.

Midazolamis a benzodiazepine used for procedural sedation, and to treat severe agitation. Midazolam induces sleepiness, decreases anxiety, and causes amnesia.It has a fast onset time for sedative effects and a fast recovery period.

The combination of midazolam and ketamine provides effective procedural sedation and analgesia and appears to be safe in pediatric patients.

Therefore, we planned to compare the efficacy of the Dexmedetomidine-Ketamine and Midazolam- Ketamine combination for sedo-analgesia in pediatric patients undergoing infraumbilical surgeries under caudal epidural block.

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
1.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I to III
  • Infraumbilical elective surgeries.

排除标准

  • Patient’s parents or caretaker’s refusal.
  • Allergy to the drugs used in the study.
  • Pre-existing neuromuscular disorder or spinal deformities.
  • Raised ICT (Intra Cranial Tension).
  • Coagulation defect.
  • Local site infection.
  • Severe hypovolemia.

结局指标

主要结局

To Compare the Perioperative Sedo-Analgesic Efficacy of Intravenous Ketamine-Dexmedetomidine and Ketamine-Midazolam Combination in Paediatric Patients Posted for Infraumbilical Surgeries Under Caudal Epidural Block to-

时间窗: till end of the surgery.

1. observe limb movement at time of needle prick for caudal block.

时间窗: till end of the surgery.

2. observe onset time and level of sedation.

时间窗: till end of the surgery.

3. observe intraoperative hemodynamic parameters.

时间窗: till end of the surgery.

次要结局

  • 1) To observe quality and duration of postoperative sedation.(2) Surgeon satisfaction.)

研究者

发起方
Sardar Patel Medical College Bikaner Rahasthan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Himanshu Dhawan

Sardar Patel Medical College Bikaner

研究点 (1)

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