Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours

Cancer of Liver Clinical Trial

Official title:

Effects of Dexmedetomidine on Periprocedural Pain During Radiofrequency Ablation of Liver and Kidney Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016391
• Other study ID #: RF-01
• Secondary ID: 2013/409
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2013
• Last updated: December 16, 2014
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• 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 he study is to evaluate effects of dexmedetomidine on pain during radiofrequency ablation of liver and kidney tumours.

Description:

Although radiofrequency ablation (RF) is accepted as the best therapeutic choice for patients with early stage hepatocellular carcinoma when liver transplantation or surgical resection are not suitable options, it is still performed only in a few hospitals and experience is so far limited (Goldberg & Ahmed, 2002; Shiina et al., 2005). In addition, RF ablation is emerging as a viable alternative to surgery for inoperable patients with limited hepatic metastatic disease, especially from colorectal cancer. Although radiofrequency ablation has been accepted as a safe and effective treatment for liver and kidney tumours, there are few studies addressing periprocedural pain.

Thus, the optimal anaesthetic procedure is still to be determined. Currently at our institution RF is performed as monitored sedation procedure using remifentanil infusion supplemented with midazolam boluses, when considered necessary. However, when using remifentanil and midazolam combination it is quite difficult to avoid too deep respiratory depression.

Dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic effects, and it has more selective α2-adrenergic effect than clonidine. Dexmedetomidine has a great deal of potential in this arena given its analgesic and anxiolytic properties while preserving respiratory drive (Bergese SD et al., 2010).

All patients will receive dexmedetomidine 0.4 µg/kg/hr infusion from the start of procedure. The infusion will be continued during the whole RF procedure.

At the same time all patients will receive remifentanil infusion according to TCI (target controlled infusion) protocol. Plasma concentration target will be set from 0.5 ng/ml and, if necessary, will be increased to achieve a comfortable state of patient (Ramsey Sedation Scale: 2-3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• liver or/and kidney cancer for which radiofrequency ablation procedure is planned

• signed informed consent form

Exclusion Criteria:

• patient refusal

• pregnancy

• known allergy to dexmedetomidine or remifentanil

• atrioventricular block grade II or III or other significant cardiac conduction disturbance

• stroke

• 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 Kidney and Renal Pelvis
• Cancer of Liver
• Carcinoma, Renal Cell
• Liver Neoplasms

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine 0.4 µg/kg/hr infusion during RF procedure

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction With Sedation 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 extremely satisfied	After completion of procedure (within 15 minutes)	No
Secondary	Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate		During procedure and up to 2 hours stay at the post-anesthesia care unit	No
Secondary	Ramsey Sedation Scale Score	Rating of depth of sedation. Scale 1 - 6, 1 being wide awake and 6 being non-responsive	During the procedure and up to 2 hours stay at the post-anesthesia care unit	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 procedure and up to 2 hours stay at the post-anesthesia care unit	No