Clinical trial NCT05402189: Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioids in Cleft Palate Repaire
Official title: Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ketodex Versus Opioids Based Anaesthesia in Cleft Palate Repair
Keywords: Ketodex, opioids, cleft palate
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective interventional randomized study
Primary purpose: TREATMENT

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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: postoperative respiratory depression
timeFrame: 4 months after starting the study
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University
Study officials:
References: