Effects of Dexmedetomidine During IRE Procedures for Solid Tumours
Conditions
Cancer of Liver - Cancer of Pancreas
Conditions: official terms
Liver Neoplasms - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 4
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Dexmedetomidine
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. liver or/and pancreas cancer for which IRE procedure is planned

2. signed informed consent form

Exclusion Criteria:

1. patient refusal

2. pregnancy

3. known allergy to dexmedetomidine or other anaesthesia drugs

4. atrioventricular block grade II or III or other significant cardiac conduction disturbance

5. stroke

6. low blood pressure not responding to treatment
Location
Uppsala University Hospital
Uppsala, Sweden
Status: Recruiting
Contact: Egidijus Semenas, MD, PhD - +72-200-4334 - egidijus.semenas@gmail.com
Start Date
January 2014
Completion Date
April 2015
Sponsors
Uppsala University Hospital
Source
Uppsala University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page