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Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

U

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)

30 participants in 1 patient group

Dexmedetomidine
Experimental group
Description:
Dexmedetomidine infusion during anaesthesia for IRE procedure
Treatment:
Drug: Dexmedetomidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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