Clinical trial NCT02044224: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer of Liver
Cancer of Pancreas
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Patient Satisfaction With Anaesthesia Technique
timeFrame: At the discharge from post-anaesthesia care room (up to 4 hours after the procedure)
Secondary outcomes:
measure: Evaluation of anaesthetic consumption
timeFrame: During anaesthesia
measure: Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate
timeFrame: During procedure and up to 4 hours stay at the post-anesthesia care unit
measure: Postoperative analgesic requirements
timeFrame: During the first 24 hours after procedure
measure: Maximal pain intensity
timeFrame: During stay at the post-anesthesia care unit (up to 4 hr) and during the first 24 hours after procedure
measure: Description of patient characteristics
timeFrame: During one week before preoperative visit at anaesthesia clinic
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital, Uppsala, Sweden
name: Egidijus Semenas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University Hospital, Uppsala, Sweden
name: Mats Eriksson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones CR. Perioperative uses of dexmedetomidine. Int Anesthesiol Clin. 2013 Spring;51(2):81-96. doi: 10.1097/AIA.0b013e31828d58c7. No abstract available.
citation: Yazbek-Karam VG, Aouad MM. Perioperative uses of dexmedetomidine. Middle East J Anaesthesiol. 2006 Oct;18(6):1043-58. No abstract available.
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.
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.
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.