Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

October 19, 2015 updated by: Egidijus Semenas, Uppsala University Hospital

Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine
Dexmedetomidine infusion during anaesthesia for IRE procedure
Drug: Dexmedetomidine

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the discharge from post-anaesthesia care room (up to 4 hours after the procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of anaesthetic consumption
Time Frame: During anaesthesia
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
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
During the first 24 hours after procedure
Maximal pain intensity
Time Frame: 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
During stay at the post-anesthesia care unit (up to 4 hr) and during the first 24 hours after procedure
Description of patient characteristics
Time Frame: During one week before preoperative visit at anaesthesia clinic
Primary disease, concomitant diseases, medications, allergies
During one week before preoperative visit at anaesthesia clinic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Investigators

  • Principal Investigator: Egidijus Semenas, MD, PhD, Uppsala University Hospital, Uppsala, Sweden
  • Principal Investigator: Mats Eriksson, MD, PhD, Uppsala University Hospital, Uppsala, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRE-01
  • 2013/413 (Other Identifier: Uppsala Regional Ethics Committe)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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