Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours

Sponsor

Uppsala University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02016391

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of he study is to evaluate effects of dexmedetomidine on pain during radiofrequency ablation of liver and kidney tumours.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Kidney and Renal Pelvis Cancer of Liver	Drug: Dexmedetomidine	Phase 4

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine	Drug: Dexmedetomidine Dexmedetomidine 0.4 µg/kg/hr infusion during RF procedure

Arm

Intervention/Treatment

Experimental: Dexmedetomidine

Drug: Dexmedetomidine

Dexmedetomidine 0.4 µg/kg/hr infusion during RF procedure

Outcome Measures

Primary Outcome Measures

Patient Satisfaction With Sedation Technique [After completion of procedure (within 15 minutes)]
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

Secondary Outcome Measures

Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate [During procedure and up to 2 hours stay at the post-anesthesia care unit]
Ramsey Sedation Scale Score [During the procedure and up to 2 hours stay at the post-anesthesia care unit]
Rating of depth of sedation. Scale 1 - 6, 1 being wide awake and 6 being non-responsive
Maximal pain intensity [During procedure and up to 2 hours stay at the post-anesthesia care unit]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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