Clinical trial NCT05752903: Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation of CT Guided Bone Biopsy
Official title: Comparison Between Dexmedetomidine-Propofol and Ketamine-Propofol Administration for Sedation of CT Guided Bone Biopsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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

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

Primary outcomes:
measure: Heart rate
timeFrame: before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
Secondary outcomes:
measure: Mean arterial blood pressure
timeFrame: before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
measure: Visual analogue scale (VAS) score for pain
timeFrame: every 15 minutes for one hour postoperatively
measure: recovery time
timeFrame: immediately postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National cancer institute
Study officials:
affiliation: National Cancer Institute (NCI)
name: Ahmed Salah abdelgalil, MD
role: PRINCIPAL_INVESTIGATOR
References: