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Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours

Primary Purpose

Cancer of Kidney and Renal Pelvis, Cancer of Liver

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Kidney and Renal Pelvis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexmedetomidine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate
Ramsey Sedation Scale Score
Rating of depth of sedation. Scale 1 - 6, 1 being wide awake and 6 being non-responsive
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

Full Information

First Posted
December 10, 2013
Last Updated
December 16, 2014
Sponsor
Uppsala University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02016391
Brief Title
Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours
Official Title
Effects of Dexmedetomidine on Periprocedural Pain During Radiofrequency Ablation of Liver and Kidney Tumours
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Kidney and Renal Pelvis, Cancer of Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine 0.4 µg/kg/hr infusion during RF procedure
Primary Outcome Measure Information:
Title
Patient Satisfaction With Sedation Technique
Description
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
Time Frame
After completion of procedure (within 15 minutes)
Secondary Outcome Measure Information:
Title
Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate
Time Frame
During procedure and up to 2 hours stay at the post-anesthesia care unit
Title
Ramsey Sedation Scale Score
Description
Rating of depth of sedation. Scale 1 - 6, 1 being wide awake and 6 being non-responsive
Time Frame
During the procedure and up to 2 hours stay at the post-anesthesia care unit
Title
Maximal pain intensity
Description
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
Time Frame
During procedure and up to 2 hours stay at the post-anesthesia care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egidijus Semenas, MD, PhD
Organizational Affiliation
Uppsala University Hospital, Uppsala, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mats Eriksson, MD, PhD
Organizational Affiliation
Uppsala University Hospital, Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

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Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours

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