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Clinical trial

Comparison Between Dexmedetomidine-Propofol and Ketamine-Propofol Administration for Sedation of CT Guided Bone Biopsy: A Randomized Controlled Trial

ID
Name
AP2207-50109
Description
This study aims to compare the effectiveness and safety of a dexmedetomidine-propofol combination and a ketamine-Propofol combination for sedation of CT guided bone biopsy.
Trial arms
Trial start
2023-03-04
Estimated PCD
2023-09-10
Trial end
2023-09-15
Status
Completed
Phase
Early phase I
Treatment
Dexmedetomidine-propofol
1 microgram/kg dexmedetomidine+2.5 mg/kg propofol intravenous (IV) bolus, 0.5 microgram g/kg/h dexmedetomidine+2.5 mg/kg/h propofol infusion
Arms:
Dexmedetomidine-propofol
Other names:
precedex
Ketamine-Propofol
1 mg/kg ketamine+2.5 mg/kg propofol iv bolus, 0.25 mg/kg/h ketamine+2.5mg/kg/h propofol infusion
Arms:
ketamine-propofol
Other names:
ketofol
Size
60
Primary endpoint
Heart rate
before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
Eligibility criteria
Inclusion Criteria: * Stated willingness to comply with all study procedures and availability for the duration of the study . * Age between 18 to 60 years old * American Society of Anesthesiologists (ASA) physical I-III * Scheduled for CT guided bone biopsy with sedation. Exclusion Criteria: * Severe heart, lung, and liver disease * kidney failure * Bleeding diathesis Allergy to drugs to be used
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-09-28

1 organization

2 products

1 indication

Organization
National Cancer Institute, Egypt
Product
Dexmedetomidine-propofol
Indication
Sedation
Product
Ketamine-Propofol