Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02044224
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Egidijus Semenas, Uppsala University Hospital

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

Condition or disease Intervention/treatment Phase
Cancer of Liver Cancer of Pancreas Drug: Dexmedetomidine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours
Study Start Date : January 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluation of anaesthetic consumption [ Time Frame: During anaesthesia ]
  2. 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 ]
  3. Postoperative analgesic requirements [ Time Frame: During the first 24 hours after procedure ]
  4. 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

  5. Description of patient characteristics [ Time Frame: During one week before preoperative visit at anaesthesia clinic ]
    Primary disease, concomitant diseases, medications, allergies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044224


Locations
Layout table for location information
Sweden
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Egidijus Semenas, MD, PhD Uppsala University Hospital, Uppsala, Sweden
Principal Investigator: Mats Eriksson, MD, PhD Uppsala University Hospital, Uppsala, Sweden

Publications:
Layout table for additonal information
Responsible Party: Egidijus Semenas, Consultant in anaesthesia and intensive care, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT02044224    
Other Study ID Numbers: IRE-01
2013/413 ( Other Identifier: Uppsala Regional Ethics Committe )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action