Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation of CT Guided Bone Biopsy
Comparison Between Dexmedetomidine-Propofol and Ketamine-Propofol Administration for Sedation of CT Guided Bone Biopsy: A Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2023
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 3, 2023
CompletedStudy Start
First participant enrolled
March 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2023
CompletedSeptember 28, 2023
March 1, 2023
6 months
February 21, 2023
September 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Heart rate
change in heart rate
before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
Secondary Outcomes (3)
Mean arterial blood pressure
before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
Visual analogue scale (VAS) score for pain
every 15 minutes for one hour postoperatively
recovery time
immediately postoperative
Study Arms (2)
Dexmedetomidine-propofol
ACTIVE COMPARATORDexmedetomidine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure
ketamine-propofol
ACTIVE COMPARATORketamine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure
Interventions
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
1 mg/kg ketamine+2.5 mg/kg propofol iv bolus, 0.25 mg/kg/h ketamine+2.5mg/kg/h propofol infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Severe heart, lung, and liver disease
- kidney failure
- Bleeding diathesis Allergy to drugs to be used
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National cancer institute
Cairo, 11769, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Salah abdelgalil, MD
National Cancer Institute (NCI)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 3, 2023
Study Start
March 4, 2023
Primary Completion
September 10, 2023
Study Completion
September 15, 2023
Last Updated
September 28, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share