NCT02044224

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

January 20, 2014

Last Update Submit

October 19, 2015

Conditions

Cancer of LiverCancer of Pancreas

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (5)

  • 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

  • Description of patient characteristics

    During one week before preoperative visit at anaesthesia clinic

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine infusion during anaesthesia for IRE procedure

Drug: Dexmedetomidine

Interventions

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

Dexmedetomidine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (5)

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

    PMID: 23532129BACKGROUND

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

    PMID: 17263262BACKGROUND

  • 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.

    PMID: 19947802BACKGROUND

  • 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.

    PMID: 23369152BACKGROUND

  • 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.

    PMID: 20142349BACKGROUND

MeSH Terms

Conditions

Liver NeoplasmsPancreatic Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Egidijus Semenas, MD, PhD

    Uppsala University Hospital, Uppsala, Sweden

    PRINCIPAL INVESTIGATOR

  • Mats Eriksson, MD, PhD

    Uppsala University Hospital, Uppsala, Sweden

    PRINCIPAL INVESTIGATOR

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

January 20, 2014

First Posted

January 23, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations

SE(1)