Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

Uppsala University Hospital

Status and phase: Completed; Phase 4

Conditions: Cancer of Pancreas; Cancer of Liver

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02044224

2013/413 (Other Identifier)

IRE-01

Details and patient eligibility

About

The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE procedures for solid tumours

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Dexmedetomidine

Experimental group

Description:

Dexmedetomidine infusion during anaesthesia for IRE procedure

Treatment:

Drug: Dexmedetomidine