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临床试验/NCT05874245
NCT05874245招募中4 期

PERIOPERATIVE EFFECTS OF ORAL DEXMEDETOMIDINE, KETAMINE, OR MIDAZOLAM PREMEDICATION IN CHILDREN UNDERGOING ADENOTONSILLECTOMY

Menoufia University1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
222
试验地点
1
主要终点
measure sedative effectes of Dexmedetomidine, Ketamine, or Midazolam using modified observer's assessment of alertness/sedation scale and parental separation anxiety scale.

研究概览

简要总结

Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.

In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.

Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.

An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents. [5]

Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.

Premedication may also induce amnesia, the prevention of physiologic stress, vagolysis, a decrease in total anesthetic requirements, a lower likelihood of aspiration, decreased salivation and secretions, antiemesis, and analgesia. All drugs have the potential to make people sleepy and slow their breathing, so they must be given with extreme care and closely watched.

Ketamine is a useful sedative and analgesic for preventing preoperative anxiety in children; it exerts its analgesic effect through the reversible antagonist action of N-methyl-D-aspartate receptors. It has analgesic and sedative effects in different doses of administration. Ketamine is often administered orally and is αreported to be safe and effective in pediatric patients.

An effective sedative and analgesic with minimal respiratory depressive effects is dexmedetomidine, an α2-adrenoceptor agonist. It also reduces the hemodynamic stress response due to its sympatholytic effect. These characteristics make it a possible anesthetic premedication.

Midazolam, a water-soluble benzodiazepine, is commonly used as a preanesthetic medicine in children due to its several favorable effects: sedation, anxiolysis, antegrade amnesia, rapid onset, and brief duration of action.

Adenoidectomy and/or tonsillectomy are the most common surgical procedures done on children.

Hence, the present study will be conducted to objectively evaluate, the perioperative effects of oral dexmedetomidine, ketamine, or midazolam premedication in patients undergoing adenotonsillectomy.

详细描述

Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.

In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.

Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.

An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents.

Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.

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)

盲法说明

All are blinded

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All patients within the age range of 3 to 8 years old.
  • Elective non complicated adenotonsillectomy.
  • ASA I or II physical status.

排除标准

  • Refusal of the patient's parents or legal guardians to give informed consent.
  • History of allergy to any of the study drugs.
  • Preoperative intake of opioid or non-steroidal anti-inflammatory drugs within 24 h before surgery.
  • Neurological and/or psychological diseases.
  • Associated cardio-respiratory illness

研究组 & 干预措施

Group D; oral Dexmedetomidine

Experimental

will receive 4 micrograms/kg oral Dexmedetomidine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia.

干预措施: oral Dexmedetomidine (Drug)

Group K; oral ketamine group

Experimental

will receive 6 mg/kg oral Ketamine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg 45 minutes before the induction of anaesthesia.

干预措施: oral ketamine (Drug)

Group M; oral Midazolam group

Experimental

will receive 0.3 mg/kg (maximum 20 mg) oral Midazolam diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia.

干预措施: oral Midazolam (Drug)

结局指标

主要结局

measure sedative effectes of Dexmedetomidine, Ketamine, or Midazolam using modified observer's assessment of alertness/sedation scale and parental separation anxiety scale.

时间窗: 12 months

measure sedative effectes of Dexmedetomidine, Ketamine, or Midazolam using modified observer's assessment of alertness/sedation scale and parental separation anxiety scale.

次要结局

  • Amount of analgesia required postperative by Face, Legs, Activity, Cry, Consolability (FLACC) Behavioural Pain Scale.(12 months)
  • Measure Emergence agitation by Richmond Agitation-Sedation Scale (RASS)(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed elsayed mahmoud abousayar

Principal Investigator

Menoufia University

研究点 (1)

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