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
Primary Purpose
Ketodex Versus Opioids Based Anaesthesia in Cleft Palate Repair
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ketodex, Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Ketodex Versus Opioids Based Anaesthesia in Cleft Palate Repair focused on measuring Ketodex, opioids, cleft palate
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
Sites / Locations
- Faculty of Medicine Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ketodex group : Group (KD)
Opioid group: Group (OP)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05402189
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 10, 2022 (Anticipated)
Study Completion Date
June 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketodex Versus Opioids Based Anaesthesia in Cleft Palate Repair
Keywords
Ketodex, opioids, cleft palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
prospective interventional randomized study
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketodex group : Group (KD)
Arm Type
Active Comparator
Arm Title
Opioid group: Group (OP)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ketodex, Fentanyl
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative respiratory depression
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa M Mohamed, Lecturer
Phone
01000205686
Email
marwaemam600@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A Noser, Lecturer
Phone
01025841934
Facility Information:
Facility Name
Faculty of Medicine Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwa M Mamdouh, Lecturer
Phone
01000205686
Email
marwaemam600@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed A Noser, Lecturer
Phone
01025841933
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs