Effects of Dexmedetomidine During IRE Procedures for Solid Tumours
Primary Purpose
Cancer of Liver, Cancer of Pancreas
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Liver
Eligibility Criteria
Inclusion Criteria:
- liver or/and pancreas cancer for which IRE procedure is planned
- signed informed consent form
Exclusion Criteria:
- patient refusal
- pregnancy
- known allergy to dexmedetomidine or other anaesthesia drugs
- atrioventricular block grade II or III or other significant cardiac conduction disturbance
- stroke
- low blood pressure not responding to treatment
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dexmedetomidine
Arm Description
Dexmedetomidine infusion during anaesthesia for IRE procedure
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Evaluation of anaesthetic consumption
Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate
Postoperative analgesic requirements
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
Description of patient characteristics
Primary disease, concomitant diseases, medications, allergies
Full Information
NCT ID
NCT02044224
First Posted
January 20, 2014
Last Updated
October 19, 2015
Sponsor
Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02044224
Brief Title
Effects of Dexmedetomidine During IRE Procedures for Solid Tumours
Official Title
Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Liver, Cancer of Pancreas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine infusion during anaesthesia for IRE procedure
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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 Measure Information:
Title
Patient Satisfaction With Anaesthesia Technique
Description
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 Outcome Measure Information:
Title
Evaluation of anaesthetic consumption
Time Frame
During anaesthesia
Title
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
Title
Postoperative analgesic requirements
Time Frame
During the first 24 hours after procedure
Title
Maximal pain intensity
Description
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
Title
Description of patient characteristics
Description
Primary disease, concomitant diseases, medications, allergies
Time Frame
During one week before preoperative visit at anaesthesia clinic
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
liver or/and pancreas cancer for which IRE procedure is planned
signed informed consent form
Exclusion Criteria:
patient refusal
pregnancy
known allergy to dexmedetomidine or other anaesthesia drugs
atrioventricular block grade II or III or other significant cardiac conduction disturbance
stroke
low blood pressure not responding to treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egidijus Semenas, MD, PhD
Organizational Affiliation
Uppsala University Hospital, Uppsala, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mats Eriksson, MD, PhD
Organizational Affiliation
Uppsala University Hospital, Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
23532129
Citation
Jones CR. Perioperative uses of dexmedetomidine. Int Anesthesiol Clin. 2013 Spring;51(2):81-96. doi: 10.1097/AIA.0b013e31828d58c7. No abstract available.
Results Reference
background
PubMed Identifier
17263262
Citation
Yazbek-Karam VG, Aouad MM. Perioperative uses of dexmedetomidine. Middle East J Anaesthesiol. 2006 Oct;18(6):1043-58. No abstract available.
Results Reference
background
PubMed Identifier
19947802
Citation
Barletta JF, Miedema SL, Wiseman D, Heiser JC, McAllen KJ. Impact of dexmedetomidine on analgesic requirements in patients after cardiac surgery in a fast-track recovery room setting. Pharmacotherapy. 2009 Dec;29(12):1427-32. doi: 10.1592/phco.29.12.1427.
Results Reference
background
PubMed Identifier
23369152
Citation
Cheung W, Kavnoudias H, Roberts S, Szkandera B, Kemp W, Thomson KR. Irreversible electroporation for unresectable hepatocellular carcinoma: initial experience and review of safety and outcomes. Technol Cancer Res Treat. 2013 Jun;12(3):233-41. doi: 10.7785/tcrt.2012.500317. Epub 2013 Jan 25.
Results Reference
background
PubMed Identifier
20142349
Citation
Ball C, Thomson KR, Kavnoudias H. Irreversible electroporation: a new challenge in "out of operating theater" anesthesia. Anesth Analg. 2010 May 1;110(5):1305-9. doi: 10.1213/ANE.0b013e3181d27b30. Epub 2010 Feb 8.
Results Reference
background
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Effects of Dexmedetomidine During IRE Procedures for Solid Tumours
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