Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours
Effects of Dexmedetomidine on Periprocedural Pain During Radiofrequency Ablation of Liver and Kidney Tumours
2 other identifiers
interventional
50
1 country
1
Brief Summary
The purpose of he study is to evaluate effects of dexmedetomidine on pain during radiofrequency ablation of liver and kidney tumours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
December 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 17, 2014
December 1, 2014
1 year
December 10, 2013
December 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (3)
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
Maximal pain intensity
During procedure and up to 2 hours stay at the post-anesthesia care unit
Study Arms (1)
Dexmedetomidine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- liver or/and kidney cancer for which radiofrequency ablation procedure is planned
- signed informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uppsala University Hospital
Uppsala, 75185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Egidijus Semenas, MD, PhD
Uppsala University Hospital, Uppsala, Sweden
- PRINCIPAL INVESTIGATOR
Mats Eriksson, MD, PhD
Uppsala University Hospital, Uppsala, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant in anaesthesia and intensive care
Study Record Dates
First Submitted
December 10, 2013
First Posted
December 20, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 17, 2014
Record last verified: 2014-12