跳至主要内容
临床试验/CTRI/2024/04/066183
CTRI/2024/04/066183尚未招募Phase 3 4

A Comparative study of oral Dexmedetomidine,Ketamine alone Versus a combination of both as premedication in paediatric patients posted for surgery

Shahin c1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月30日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Compare the effects of Dexmedetomidine, Ketamine and combination of both in sedation, analgesia and reducing anxiety

研究概览

简要总结

INTRODUCTION:  Anaesthesia and Surgery can be stressful and traumatic experiences for children. They are especially vulnerable to long term Psychological Impairment resulting from stress. Incidence of pre-op anxiety is about 60-70 %in paediatric patients. This is associated with increased risks of negative effects as difficult induction, post-operative agitation and increased post-op pain.

Premedication are frequently administered in children to alleviate the stress and fear of treatmen well as to ease child-parent separation and promote a smooth induction of anaesthesia. Different kinds of medications have been used for pre-medication such as anticholinergic drugs, opioids, benzodiazepines and ketamine. On literature search there are various studies on Oral midazolam, In those studies It alleviates an

and provide adequate sedation but has increased Risk of Respiratory Depression. Various studies

have been done for Oral premedication as alone or in combination, comparing Ketamine and

Midazolam, but very few studies compared the Oral Dexmedetomidine and Oral Ketamine. Clonidine has significant analgesic properties because of its alpha-2-adrenergic agonism. One major downside of clonidine is longer duration of onset requiring administration 60 minutes before anaesthesia induction. Ketamine is an easily administered parental anaesthetic that produces profound analgesia in sub- anaesthetic doses and lacks the cardiorespiratory depression seen with most other general anaesthetics. Ketamine is a phencyclidine derivative which acts on the n-methyl d-aspartate rece and causes central dissociation of the cerebral cortex while providing amnesia and analgesia and applied for premedication in different studies. Ketamine is most commonly used as premedicatio have been used to provide sedation and analgesia but may cause Nausea and Vomiting. New Drugs such as Dexmedetomidine which is an Alpha-2-Agonist have emerged as an alternative for Premedication in Paediatric Anaesthesia having sedative, analgesic and anxiolytic property minimal respiratory depression and better Peri Operative Haemodynamic stability. Dexmedetomidine and ketamine exhibit complementary pharmacological effects. Dexmedetomidine reduces cardiovascular responses and postoperative psychiatric adverse reactions attributed to

AIMS OF THE STUDY:

Primary: Compare the effects of Dexmedetomidine, Ketamine and combination of both in sedation, analgesia and reducing anxiety

Secondary: Our study will compare oral Dexmedetomedine, oral ketamine and combination of both in their effects on the ease of separation from parents, the acceptance for IV

cannulation and face mask application Expected outcome: To know the better pre-medication drug among children between oral

ketamine, oral dexmedetomidine and combination of both

METHODOLOGY OF THE STUDY:

This will be a Randomised, Comparative. Double Blinded Prospective Study of 90 Patients between 2- 12 Years of Age.

All Patients of ASA I and II Posted for Surgery between 2-12 years of age will be enrolled in the Study.

RISKS

No major risk involved

BENEFITS OF THE STUDY

Smooth induction

Less peri-operative anxiety

Less requirement of additional sedative doses of Ketamine

Easy parental separation

IV acceptability is good

Easy mask acceptance

Convenient and appealing method of sedation

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator 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 with ASA 1 or 2 patients posted for elective surgery.

排除标准

  • Patients below age 2 and above age 12 patient belonging to ASA grade more than 2 Patient undergoing any emergency surgry syndromic children Child with Respiratory Tract Infections.

结局指标

主要结局

Compare the effects of Dexmedetomidine, Ketamine and combination of both in sedation, analgesia and reducing anxiety

时间窗: The level of sedation of the patient will be examined before and after 5,10,20,30,40,60 minutes of giving premedicvation on a five point scale (SS-5) | 1.Rarely awake,responds to shouting or shaking | 2.Asleep eyes closed | 3.Sleepy but eyes open spontaneously | 4.Awake | 5.Agitated

次要结局

  • study will compare oral Dexmedetomedine, oral ketamine and combination of both in their effects on the ease of separation from parents, the acceptance for IV cannulation and face mask application(After assessing the level of sedation, i.e., 40 minutes from giving the pre-medication, the difficulty in separating the patients from their parents will be evaluated on a 4 point scale)

研究者

发起方
Shahin c
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shahin c

Pandit Deendayal Upadhyay Medical College, Rajkot

研究点 (1)

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