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Completed

NCT Number: NCT02044224

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Uppsala University Hospital

Uppsala, 75185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • liver or/and pancreas cancer for which IRE procedure is planned
  • signed informed consent form

Exclusion criteria

  • patient refusal
  • pregnancy
  • known allergy to dexmedetomidine or other anaesthesia drugs
  • atrioventricular block grade II or III or other significant cardiac conduction disturbance
  • stroke
  • low blood pressure not responding to treatment

Treatment and study plan

Dexmedetomidine

Drug

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

Primary outcomes

  1. Patient Satisfaction With Anaesthesia Technique

    Time frame: 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 outcomes

  1. Evaluation of anaesthetic consumption

    Time frame: During anaesthesia

  2. Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate

    Time frame: During procedure and up to 4 hours stay at the post-anesthesia care unit

  3. Postoperative analgesic requirements

    Time frame: During the first 24 hours after procedure

  4. Maximal pain intensity

    Time frame: 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

  5. Description of patient characteristics

    Time frame: During one week before preoperative visit at anaesthesia clinic

    Primary disease, concomitant diseases, medications, allergies

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Official study title

Effects of Dexmedetomidine on Anaesthesia During IRE Procedures for Solid Tumours

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2014
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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