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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.
Assessment of boney lesions is an common activity in the care of cancer patients. CT guided Percutaneous needle biopsies have a low complication rate. usually, this procedure is done under sedation.
Propofol is a non-barbiturate hypnotic and sedative. It facilitates gamma-aminobutyric acid mediated inhibitory neurotransmission. It's known to have anti-emetic, antipruritic, anticonvulsant and amnestic effects. Despite being effective and potent, Propofol's main disadvantages is its dose-dependent hypotension and respiratory depression .Ketamine is a phencyclidine derivative which acts as a N-methyl-D-aspartate (NMDA) receptor antagonist. It is a dissociative anesthetic and provides some analgesia. It maintains airway reflexes and spontaneous respiration. Combining Propofol and ketamine preserves the sedative and analgesic efficacy while reducing their adverse effects. Dexmedetomidine is a highly selective α2-agonist. It is eight times more specific compared with clonidine. It has a perioperative anxiolytic, sedative properties as well as some analgesic properties .Dexmedetomidine is usually used for mild to moderate sedation and Propofol could be added to deepen the level of sedation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine-propofol | Active Comparator | Dexmedetomidine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure |
|
| ketamine-propofol | Active Comparator | ketamine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine-propofol | Drug | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | change in heart rate | before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial blood pressure | change in the 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Salah abdelgalil, MD | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National cancer institute | Cairo | 11769 | Egypt |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Ketamine-Propofol | Drug | 1 mg/kg ketamine+2.5 mg/kg propofol iv bolus, 0.25 mg/kg/h ketamine+2.5mg/kg/h propofol infusion |
|
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assessment of postoperative pain using the visual analogue scale score. the scale is a straight horizontal line (100 mm). The ends are defined as the extreme limits of pain orientated from the left (no pain) to the right (worst pain).The patient marks on the line the point that they feel represents their perception of their current state.
The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.higher VAS score means worse pain
| every 15 minutes for one hour postoperatively |
| recovery time | recovery time | immediately postoperative |