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临床试验/CTRI/2024/08/072317
CTRI/2024/08/072317尚未招募Phase 3 4

Comparison Of clonidine with midazolam as pre anaesthetic oral medication in paediatric patients in Sawangi, Maharashtra

Jawaharlal Nehru Medical College1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月31日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
30
试验地点
1
主要终点
To compare oral clonidine with oral midazolam as preanaesthetic medication

研究概览

简要总结

The preoperative period is a stressful period and a major source of anxiety for all patients especially in the paediatric population. Preoperative anxiety in children is a natural response that that produces a negative experience for both patient and parent and thus warrants attention. An ideal pre anaesthetic medication should reduce separation anxiety from the parent, allow for easy and smooth induction of anaesthesia without causing prolongation of emergence or increasing post operative nausea, vomiting and delirium. Oral premedication is commonly used in paediatric population prior to surgery. The ideal pre anaesthetic agent ought to have a fast and dependable onset, negligible results, quick recuperation and ought to work with smooth acceptance of sedation

Midazolam is a water-soluble benzodiazepine. It used as a preanaesthetic medication by several routes including oral, intravenous, intranasal and intramuscular. It has sedative and amnestic effects. Midazolam is the most commonly used oral premedication used in children. Oral midazolam syrup (2 mg/ml) is effective for producing sedation and anxiolysis at a dose of 0.25 mg/kg with minimal effects on ventilation and oxygen saturation even when administered at doses as large

As 1 mg/kg (maximum, 20 mg). Midazolam, 0.5 mg/kg administered orally 30 minutes before induction of anesthesia, provides reliable sedation and anxiolysis in children without producing delayed awakening. Although it is recommended that oral midazolam be administered at least 20 minutes before surgery, there is evidence that significant anterograde amnesia is present when 0.5 mg/kg orally is administered 10 minutes before surgery.

Clonidine is partial α2 receptor agonist. Premedication with clonidine produces preoperative sedation and anxiolysis in children. It also has analgesic properties, decreases volatile anesthetic requirements and improves perioperative hemodynamic stability. Although clonidine is not as common as midazolam as a premedication, it is slowly gaining popularity. It also reduces the requirements for both inhaled anesthetics during surgery as well as opioids in the postoperative period.

Major postoperative issues include pain, emergence delirium, airway obstruction, and hypoventilation. Opioids for pain management can exacerbate airway obstruction and hypoventilation and increase postoperative emesis. Nonsteroidal anti-inflammatory Drugs such as ketorolac are not associated with the respiratory depressant and emetic side effects of opioid administration, but are associated with increased bleeding.Aim

This study aims to Compare the efficacy of oral midazolam as a pre anaesthetic medication to oral clonidine in paediatric patients undergoing tonsillectomy.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
2.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 2-12 years
  • Patients posted for surgery under general anaesthesia
  • Patients whose parents/ guardians provide consent.

排除标准

  • 1.Patients less than 2 year of age 2.Patients more than 12 years of age
  • Weight of more than 95th percentile for age
  • Patients with a difficult airway
  • Patients with central nervous system disorders
  • Patients on anticonvulsants or sedative medications 8.

结局指标

主要结局

To compare oral clonidine with oral midazolam as preanaesthetic medication

时间窗: 1. at separation | 2. at venepuncture | 3. at mask application

次要结局

  • Comparison of haemodynamic status of patients recieving oral clonidine & oral midazolam(1. at separation)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shyamolima Bhuyan

Jawaharlal Nehru Medical College

研究点 (1)

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