- ICH GCP
- US Clinical Trials Registry
- 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
Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Marwa M Mohamed, Lecturer
- Phone Number: 01000205686
- Email: marwaemam600@gmail.com
Study Contact Backup
- Name: Mohamed A Noser, Lecturer
- Phone Number: 01025841934
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Faculty of Medicine Ain shams University
-
Contact:
- Marwa M Mamdouh, Lecturer
- Phone Number: 01000205686
- Email: marwaemam600@gmail.com
-
Contact:
- Mohamed A Noser, Lecturer
- Phone Number: 01025841933
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ketodex group : Group (KD)
|
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. |
Active Comparator: Opioid group: Group (OP)
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative respiratory depression
Time Frame: 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
|
4 months after starting the study
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Mouth Abnormalities
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Cleft Palate
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- FMASU R 10 2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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