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临床试验/NCT05402189
NCT05402189Unknown1 期

Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
50
试验地点
1
主要终点
postoperative respiratory depression

研究概览

简要总结

This study will be conducted to compare Ketodex versus opioid based anaesthesia in cleft palate repair surgeries .

详细描述

According to patients' randomized groups, study medication is given at induction and continues intraoperative not more than 2hours.[8]. Induction of anaesthesia with inhalational anaesthetic will be done through a face mask and Ayres T piece (sevoflurane )8%on 100% oxygen and fresh gas flow of at least double patient minute volume and IV line will be inserted and secured in place .After confirmation of intermittent positive pressure ventilation , 1.5 mg/kg IV suxamethonium will injected. The child will be intubated with an appropriate sized tube, and a throat pack will be placed. Ventilation will be performed with a standard ventilator equipped with a paediatric circle circuit (Datex Ohmeda, Helsinki, Finland), tidal volume of 6-8 ml/kg, and a rate adjusted to maintain the ETCO2 concentration between 32 and 35 mmHg at a total gas flow of 2 L/min. General anaesthesia will be maintained with 50% O2 + 50% air with atracurium and isoflurane, which will be titrated according to the hemodynamic parameters. Dexamethasone (0.2 mg/kg) will be given as an antiemetic and to reduce airway oedema. Post-intubation, Group (KD) will receive 1mg/kg IV ketamine and 1 µg/kg dexmiditomidine IV diluted in 20 ml NS as a loading dose over 10 min followed by a maintenance infusion of ketamine at 0.1 mg/kg/hr and dexmiditomidine 0.2 µg/kg/hr. IV diluted in 20 ml NS till the end of surgery.(15-16-17) Group (OP) will receive fentanyl 2ug /kg IV diluted in 20 ml NS and another loading syringe containing 20 ml normal saline as a loading dose over 10 min followed by a maintenance infusion of another 20 ml syringes, one containing fentanyl and the other containing normal saline . Maintenance dose of fentanyl in this group will be 0.5 µg /kg/hr . Pre-operative fasting fluid deficits and intraoperative losses will be replaced with crystalloid. A single shot of intravenous antibiotic will be given. At the end of surgery, patients will be reversed with 0.05mg/kg IV neostigmine and 0.02 mg/kg atropine, and extubated after meeting the standard extubation criteria

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Randomization will be performed using a computer-generated random number table in opaque sealed envelopes with 1:1 allocation ratio by an anesthesiologist not directly involved in the trial or patient care.

  • Patients will be subsequently followed up by a researcher who will be unaware of the group allocation. Thus effectively, the patient and the outcome assessor will be blinded to the group allocation.

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 6 months to 5 years; both sex, American Society of anaesthesiologists' physical status I or II; no associated any other congenital anomalies.

排除标准

  • Patients with a history of prematurity delayed motor , mental or developmental milestones, long QT syndrome, are excluded from the study allergy to study drugs

研究组 & 干预措施

Ketodex group : Group (KD)

Active Comparator

干预措施: Ketodex, Fentanyl (Drug)

Opioid group: Group (OP)

Active Comparator

干预措施: Ketodex, Fentanyl (Drug)

结局指标

主要结局

postoperative respiratory depression

时间窗: 4 months after starting the study

This study will be conducted to compare Ketodex versus opioid based anaesthesia in cleft palate repair surgeries as regard postoperative respiratory depression and the need for oxygen

次要结局

未报告次要终点

研究者

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

Marwa Emam

Lecturer

Ain Shams University

研究点 (1)

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