Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation of CT Guided Bone Biopsy

National Cancer Institute, Egypt

Status and phase: Completed; Phase 4

Conditions: Sedation

Treatments: Drug: Dexmedetomidine-propofol; Drug: Ketamine-Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05752903

AP2207-50109

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Dexmedetomidine-propofol

Active Comparator group

Description:

Dexmedetomidine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure

Treatment:

Drug: Dexmedetomidine-propofol

ketamine-propofol

Active Comparator group

Description:

ketamine-propofol bolus will be administered then Dexmedetomidine-propofol infusion continued during the procedure

Treatment:

Drug: Ketamine-Propofol