Uppsala University Hospital
Uppsala, 75185, Sweden
NCT Number: NCT02044224
The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE procedures for solid tumours
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Uppsala, 75185, Sweden
Pulsed electric current can be used to produce irreversible electroporation (IRE) of cell membranes with resulting cell death. This process has been shown to ablate tumors in animal and human studies. A pulsating direct current of 20 to 50 A and 500 to 3000 V is delivered into metastatic or primary tumors in the liver, kidney, or lung via needle electrodes inserted under computed tomography (CT) or ultrasound guidance. Patients usually require general anesthesia with muscle relaxant. Currently, circa 30 procedures have been done at our institution with good or excellent results. However, several patients have had severe pain postoperatively.
Dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic effects, and it has more selective α2-adrenergic effect than clonidine. We will evaluate perioperative dexmedetomidine 0.4 µg/kg/hr infusion effects on hemodynamics, anesthetic consumption, and recovery profiles during anesthesia for IRE of solid organs tumours.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexmedetomidine 0.4 µg/kg/hr infusion (from the start of anaesthesia until the end of anaesthesia).
Anaesthesia induction: propofol 2 mg/kg, rocuronium 0.6 mg/kg iv, and fentanyl 2-3 mikrogram/kg.
Anaesthesia maintenance: sevoflurane and oxygen 50%, rocuronium 0.1-0.2 mg/kg iv, fentanyl 1 mikrogram/kg as required
Time frame: At the discharge from post-anaesthesia care room (up to 4 hours after the procedure)
Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extreme
Time frame: During anaesthesia
Time frame: During procedure and up to 4 hours stay at the post-anesthesia care unit
Time frame: During the first 24 hours after procedure
Time frame: During stay at the post-anesthesia care unit (up to 4 hr) and during the first 24 hours after procedure
The 11-point Numerical Rating Scale (NRS) to assess periprocedural pain. Scale of 0-10, with 0:no pain and 10: pain as bad as it could be
Time frame: During one week before preoperative visit at anaesthesia clinic
Primary disease, concomitant diseases, medications, allergies
Uppsala University Hospital
Other
Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours
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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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