Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE procedures for solid tumours

Detailed Description
-----------------
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.

Official Title
-----------------
Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours

Conditions
-----------------
Cancer of Liver, Cancer of Pancreas

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver or/and pancreas cancer for which IRE procedure is planned signed informed consent form Exclusion Criteria: patient refusal pregnancy known allergy to dexmedetomidine or other anaesthesia drugs atrioventricular block grade II or III or other significant cardiac conduction disturbance stroke low blood pressure not responding to treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Dexmedetomidine infusion during anaesthesia for IRE procedure | Drug: Dexmedetomidine<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction With Anaesthesia Technique | 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 | At the discharge from post-anaesthesia care room (up to 4 hours after the procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of anaesthetic consumption |  | During anaesthesia | 
| Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate |  | During procedure and up to 4 hours stay at the post-anesthesia care unit | 
| Postoperative analgesic requirements |  | During the first 24 hours after procedure | 
| Maximal pain intensity | 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 | During stay at the post-anesthesia care unit (up to 4 hr) and during the first 24 hours after procedure | 
| Description of patient characteristics | Primary disease, concomitant diseases, medications, allergies | During one week before preoperative visit at anaesthesia clinic |