Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

Phase 4CompletedNCT02044224

Uppsala University Hospital30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer of Liver Cancer of Pancreas

Interventions

DexmedetomidineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

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

Time frame: At the discharge from post-anaesthesia care room (up to 4 hours after the procedure)

Secondary Outcomes

Evaluation of anaesthetic consumption

Time frame: During anaesthesia

Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate

Time frame: During procedure and up to 4 hours stay at the post-anesthesia care unit

Postoperative analgesic requirements

Time frame: 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

Time frame: 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

Time frame: During one week before preoperative visit at anaesthesia clinic

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.