NCT03632460

Brief Summary

The aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 8, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

August 8, 2018

Last Update Submit

August 14, 2018

Conditions

Pain, PostoperativeOxidative Stress

Outcome Measures

Primary Outcomes (1)

  • Change in postoperative pain level using visual analogue scale

    Change in baseline postoperative pain level measured before operation, and then at 1h, 2h, 6h and 24h after operation using visual analogue scale. Visual analogue scale is numerical scale in range from 1-10, assessing pain level. Minimum score is 1, which represents- no pain to maximum score 10 which represents- the worst pain ever experienced.

    Before operation, 1 hour, 2 hour, 6 hour and 24 hour after operation

Secondary Outcomes (2)

  • analgesic consumption

    24 hour

  • oxydative stress level

    24 hour

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine

Drug: Dexmedetomidine Injection [Precedex]

Dexamethasone

ACTIVE COMPARATOR

8 mg dexamethasone added to 8 ml 0,375% ropivacaine

Drug: Dexmedetomidine Injection [Precedex]

Interventions

Dexmedetomidine Injection [Precedex]DRUG

epidural administration of dexmedetomidine added to ropivacaine

DexamethasoneDexmedetomidine

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing thoracic surgery due to malignant process of lung or oesophagus ASA (American Society of Anesthesiologists) status I-III

You may not qualify if:

  • neurological or psychiatric disease
  • corticosteroid therapy
  • anamnesis of myocardial infarct within last 6 months
  • severe aortic stenosis
  • kidney insufficiency
  • liver insufficiency
  • allergy
  • coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jasminka Persec

Zagreb, 10000, Croatia

Location

Related Publications (3)

  • Kim NY, Kwon TD, Bai SJ, Noh SH, Hong JH, Lee H, Lee KY. Effects of dexmedetomidine in combination with fentanyl-based intravenous patient-controlled analgesia on pain attenuation after open gastrectomy in comparison with conventional thoracic epidural and fentanyl-based intravenous patient-controlled analgesia. Int J Med Sci. 2017 Aug 18;14(10):951-960. doi: 10.7150/ijms.20347. eCollection 2017.

    PMID: 28924366RESULT

  • Hong JM, Kim KH, Lee HJ, Kwon JY, Kim HK, Kim HJ, Cho AR, Do WS, Kim HS. Epidural Dexamethasone Influences Postoperative Analgesia after Major Abdominal Surgery. Pain Physician. 2017 May;20(4):261-269.

    PMID: 28535549RESULT

  • Gallego-Ligorit L, Vives M, Valles-Torres J, Sanjuan-Villarreal TA, Pajares A, Iglesias M. Use of Dexmedetomidine in Cardiothoracic and Vascular Anesthesia. J Cardiothorac Vasc Anesth. 2018 Jun;32(3):1426-1438. doi: 10.1053/j.jvca.2017.11.044. Epub 2017 Dec 2.

    PMID: 29325842RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jasminka Persec, Assit Prof

    University Hospital Dubrava

    PRINCIPAL INVESTIGATOR

  • Andrej Sribar, MD

    University Hospital Dubrava

    STUDY CHAIR

Central Study Contacts

Jasminka Persec, Assist Prof

CONTACT

+385 1 2902433jasminka@kbd.hr

Andrej Sribar, MD PhD

CONTACT

+385 1 2902440andrej.sribar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof MD PhD

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 15, 2018

Study Start

September 1, 2018

Primary Completion

December 31, 2018

Study Completion

May 1, 2019

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)