Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

Phase 4

Completed

• Conditions: Cancer of Liver; Cancer of Pancreas
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT02044224
• Lead Sponsor: Uppsala University Hospital

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine infusion during anaesthesia for IRE procedure

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction With Anaesthesia Technique	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 Outcome Measures

Name	Time	Method
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	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
Description of patient characteristics	During one week before preoperative visit at anaesthesia clinic	Primary disease, concomitant diseases, medications, allergies

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden