Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

Cancer of Pancreas Clinical Trial

Official title:

Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044224
• Other study ID #: IRE-01
• Secondary ID: 2013/413
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2014
• Last updated: October 19, 2015
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of Liver
• Cancer of Pancreas
• Liver Neoplasms
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Jones CR. Perioperative uses of dexmedetomidine. Int Anesthesiol Clin. 2013 Spring;51(2):81-96. doi: 10.1097/AIA.0b013e31828d58c7. — View Citation

Yazbek-Karam VG, Aouad MM. Perioperative uses of dexmedetomidine. Middle East J Anaesthesiol. 2006 Oct;18(6):1043-58. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At the discharge from post-anaesthesia care room (up to 4 hours after the procedure)	No
Secondary	Evaluation of anaesthetic consumption		During anaesthesia	No
Secondary	Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate		During procedure and up to 4 hours stay at the post-anesthesia care unit	No
Secondary	Postoperative analgesic requirements		During the first 24 hours after procedure	No
Secondary	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	During stay at the post-anesthesia care unit (up to 4 hr) and during the first 24 hours after procedure	No
Secondary	Description of patient characteristics	Primary disease, concomitant diseases, medications, allergies	During one week before preoperative visit at anaesthesia clinic	No