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2014-01
2015-09
2015-09
30
NCT02044224
Uppsala University Hospital
Uppsala University Hospital
INTERVENTIONAL
Effects of Dexmedetomidine During IRE Procedures for Solid Tumours
The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE procedures for solid tumours
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-01-20 | N/A | 2015-10-19 |
2014-01-21 | N/A | 2015-10-20 |
2014-01-23 | N/A | 2015-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Dexmedetomidine Dexmedetomidine infusion during anaesthesia for IRE procedure | DRUG: Dexmedetomidine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Evaluation of anaesthetic consumption | During anaesthesia | |
| Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate | During procedure and up to 4 hours stay at the post-anesthesia care unit | |
| Postoperative analgesic requirements | During the first 24 hours after procedure | |
| 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 |
| Description of patient characteristics | Primary disease, concomitant diseases, medications, allergies | During one week before preoperative visit at anaesthesia clinic |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
