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Completed

NCT Number: NCT05752903

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

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.

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Key information

Conditions

Sedation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National cancer institute

Cairo, 11769, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: precedex

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

Other names: ketofol

Primary outcomes

  1. 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

  1. Mean arterial blood pressure

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

    change in the mean arterial blood pressure

  2. Visual analogue scale (VAS) score for pain

    Time frame: every 15 minutes for one hour postoperatively

    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

  3. recovery time

    Time frame: immediately postoperative

    recovery time

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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