Effects of Dexmedetomidine During IRE Procedures for Solid Tumours
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|ClinicalTrials.gov Identifier: NCT02044224|
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : October 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Liver Cancer of Pancreas||Drug: Dexmedetomidine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Dexmedetomidine infusion during anaesthesia for IRE procedure
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
- Patient Satisfaction With Anaesthesia Technique [ 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
- Evaluation of anaesthetic consumption [ Time Frame: During anaesthesia ]
- Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate [ Time Frame: During procedure and up to 4 hours stay at the post-anesthesia care unit ]
- Postoperative analgesic requirements [ Time Frame: During the first 24 hours after procedure ]
- Maximal pain intensity [ 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
- Description of patient characteristics [ Time Frame: During one week before preoperative visit at anaesthesia clinic ]Primary disease, concomitant diseases, medications, allergies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044224
|Uppsala University Hospital|
|Uppsala, Sweden, 75185|
|Principal Investigator:||Egidijus Semenas, MD, PhD||Uppsala University Hospital, Uppsala, Sweden|
|Principal Investigator:||Mats Eriksson, MD, PhD||Uppsala University Hospital, Uppsala, Sweden|