Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

• Sponsor: Uppsala University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02044224
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 20
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• 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: Jan 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Evaluation of anaesthetic consumption [During anaesthesia]

2. Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate [During procedure and up to 4 hours stay at the post-anesthesia care unit]

3. Postoperative analgesic requirements [During the first 24 hours after procedure]

4. 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

5. Description of patient characteristics [During one week before preoperative visit at anaesthesia clinic]

   Primary disease, concomitant diseases, medications, allergies

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uppsala University Hospital	Uppsala		Sweden	75185

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• Jones CR. Perioperative uses of dexmedetomidine. Int Anesthesiol Clin. 2013 Spring;51(2):81-96. doi: 10.1097/AIA.0b013e31828d58c7.
• Yazbek-Karam VG, Aouad MM. Perioperative uses of dexmedetomidine. Middle East J Anaesthesiol. 2006 Oct;18(6):1043-58. Review.

• 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
• First Posted: Jan 23, 2014
• Last Update Posted: Oct 20, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Pancreatic Neoplasms; Liver Neoplasms; Dexmedetomidine

Study Results

No Results Posted as of Oct 20, 2015