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

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752903
• Other study ID #: AP2207-50109
• Status: Completed
• Phase: Phase 4
• Start date: March 4, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2023
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Egypt	National cancer institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	change in heart rate	before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively
Secondary	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
Secondary	Visual analogue scale (VAS) score for pain	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
Secondary	recovery time	recovery time	immediately postoperative