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Cancer of LiverPhase 4NCT02044224

Effects of Dexmedetomidine During IRE Procedures for Solid Tumours

A Phase 4 study testing Dexmedetomidine in people with Cancer of Liver and Cancer of Pancreas, run by Uppsala University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE procedures for solid tumours Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Cancer of Liver, Cancer of Pancreas
What is being tested?
Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSweden
Study dates
Jan 2014to Sep 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Uppsala University Hospital

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: Effects of Dexmedetomidine on Anaesthesia 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

Read the 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.

Being tested
Dexmedetomidine
Medical subject headings
Liver Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    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

Study groups in NCT02044224
Study groupRoleWhat they receive
DexmedetomidineExperimentalDexmedetomidine infusion during anaesthesia for IRE procedure
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At the discharge from post-anaesthesia care room (up to 4 hours after the procedure)

Secondary outcomes (5)

  1. Evaluation of anaesthetic consumption

    Measured: During anaesthesia

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

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

  3. Postoperative analgesic requirements

    Measured: During the first 24 hours after procedure

  4. 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

    Measured: During stay at the post-anesthesia care unit (up to 4 hr) and during the first 24 hours after procedure

  5. Description of patient characteristics

    Primary disease, concomitant diseases, medications, allergies

    Measured: During one week before preoperative visit at anaesthesia clinic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02044224
Sponsor's protocol ID
IRE-01
Other IDs
2013/413
Status last verified
Oct 2015
First submitted
20 Jan 2014
Last updated
20 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Jones CR. Perioperative uses of dexmedetomidine. Int Anesthesiol Clin. 2013 Spring;51(2):81-96. doi: 10.1097/AIA.0b013e31828d58c7. No abstract available.

    PubMed 23532129

  • Yazbek-Karam VG, Aouad MM. Perioperative uses of dexmedetomidine. Middle East J Anaesthesiol. 2006 Oct;18(6):1043-58. No abstract available.

    PubMed 17263262

  • Barletta JF, Miedema SL, Wiseman D, Heiser JC, McAllen KJ. Impact of dexmedetomidine on analgesic requirements in patients after cardiac surgery in a fast-track recovery room setting. Pharmacotherapy. 2009 Dec;29(12):1427-32. doi: 10.1592/phco.29.12.1427.

    PubMed 19947802

  • Cheung W, Kavnoudias H, Roberts S, Szkandera B, Kemp W, Thomson KR. Irreversible electroporation for unresectable hepatocellular carcinoma: initial experience and review of safety and outcomes. Technol Cancer Res Treat. 2013 Jun;12(3):233-41. doi: 10.7785/tcrt.2012.500317. Epub 2013 Jan 25.

    PubMed 23369152

  • Ball C, Thomson KR, Kavnoudias H. Irreversible electroporation: a new challenge in "out of operating theater" anesthesia. Anesth Analg. 2010 May 1;110(5):1305-9. doi: 10.1213/ANE.0b013e3181d27b30. Epub 2010 Feb 8.

    PubMed 20142349

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine in people with Cancer of Liver and Cancer of Pancreas, run by Uppsala University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Satisfaction With Anaesthesia Technique (time frame: At the discharge from post-anaesthesia care room (up to 4 hours after the procedure)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02044224, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.

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