Cancer of Liver, Cancer of Pancreas
Conditions
Brief summary
The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE procedures for solid tumours
Detailed description
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine 0.4 µg/kg/hr infusion (from the start of anaesthesia until the end of anaesthesia). Anaesthesia induction: propofol 2 mg/kg, rocuronium 0.6 mg/kg iv, and fentanyl 2-3 mikrogram/kg. Anaesthesia maintenance: sevoflurane and oxygen 50%, rocuronium 0.1-0.2 mg/kg iv, fentanyl 1 mikrogram/kg as required
Sponsors
Uppsala University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. liver or/and pancreas cancer for which IRE procedure is planned 2. signed informed consent form
Exclusion criteria
1. patient refusal 2. pregnancy 3. known allergy to dexmedetomidine or other anaesthesia drugs 4. atrioventricular block grade II or III or other significant cardiac conduction disturbance 5. stroke 6. low blood pressure not responding to treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Anaesthesia Technique | At the discharge from post-anaesthesia care room (up to 4 hours after the procedure) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | During stay at the post-anesthesia care unit (up to 4 hr) and during the first 24 hours after procedure | 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 |
| Description of patient characteristics | During one week before preoperative visit at anaesthesia clinic | Primary disease, concomitant diseases, medications, allergies |
Countries
Sweden
Outcome results
None listed