A Phase 1 interventional study of Ketodex, Fentanyl in Ketodex Versus Opioids Based Anaesthesia in Cleft Palate Repair, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2022-06-02.
Sponsored by Ain Shams University · Phase 1, Interventional, and Treatment
This study will be conducted to compare Ketodex versus opioid based anaesthesia in cleft palate repair surgeries .
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
131 studies on the registry are indexed under Cleft Palate; 36 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 85 interventional studies indexed under Cleft Palate.
Browse Cleft Palate studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: Ketodex, Fentanyl
Drug: Ketodex, Fentanyl
The patients will be randomized into 2 groups : group (KD) and group (OP) . Two 20 ml syringes, labelled loading and another two 20 ml syringes labelled maintenance will be given to each patient according to his group. Group (KD): patients will receive 1mg/kg ketamine and 1ug/kg dexmiditomidine in their respective loading syringes diluted in 20ml normal saline. Then , they will receive ketamine 0.1 mg/kg /hr and dexmedetomidine0.2ug/kg/hr in their maintenance syringes prepared in 20 ml normal saline in a concentration of 1mg/ml ketamine and 1ug/ml dexmiditomidine respectively . Group (OP): one of the loading syringes will contain fentanyl in a dose of 2ug/kg diluted in 20 ml normal saline and the other loading syringe will contain normal saline. Then, the patients will receive 0.5ug/kg/hr fentanyl through one of the maintenance syringes while the other syringe contains normal saline.
postoperative respiratory depression
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
Time frame: 4 months after starting the study
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Ain Shams University