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Clinical Trials/NCT02044224
NCT02044224
Completed
Phase 4

Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours

Uppsala University Hospital1 site in 1 country30 target enrollmentJanuary 2014

Overview

Phase
Phase 4
Intervention
Dexmedetomidine
Conditions
Cancer of Liver
Sponsor
Uppsala University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Patient Satisfaction With Anaesthesia Technique
Status
Completed
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Egidijus Semenas

Consultant in anaesthesia and intensive care

Uppsala University Hospital

Eligibility Criteria

Inclusion Criteria

  • liver or/and pancreas cancer for which IRE procedure is planned
  • signed informed consent form

Exclusion Criteria

  • patient refusal
  • known allergy to dexmedetomidine or other anaesthesia drugs
  • atrioventricular block grade II or III or other significant cardiac conduction disturbance
  • low blood pressure not responding to treatment

Arms & Interventions

Dexmedetomidine

Dexmedetomidine infusion during anaesthesia for IRE procedure

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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(During stay at the post-anesthesia care unit (up to 4 hr) and during the first 24 hours after procedure)
  • Description of patient characteristics(During one week before preoperative visit at anaesthesia clinic)

Study Sites (1)

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