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Clinical Trials/NCT05752903
NCT05752903
Completed
Phase 4

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

National Cancer Institute, Egypt1 site in 1 country60 target enrollmentMarch 4, 2023

Overview

Phase
Phase 4
Intervention
Dexmedetomidine-propofol
Conditions
Sedation
Sponsor
National Cancer Institute, Egypt
Enrollment
60
Locations
1
Primary Endpoint
Heart rate
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 4, 2023
End Date
September 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Cancer Institute, Egypt
Responsible Party
Sponsor

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

Arms & Interventions

Dexmedetomidine-propofol

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

Intervention: Dexmedetomidine-propofol

ketamine-propofol

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

Intervention: Ketamine-Propofol

Outcomes

Primary Outcomes

Heart rate

Time Frame: before administration (baseline), every 10 minutes during the procedure, every 15 minutes for one hour postoperatively

change in heart rate

Secondary Outcomes

  • 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 Sites (1)

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