Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

NCT ID: NCT03632460

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-05-01

Brief Summary

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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

Detailed Description

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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.

Investigation will include patients between 30-70 years undergoing thoracic surgery due to malignant process of lung or oesophagus.

Patients are divided in two groups: epidural administration of 0.375% ropivacaine with 1 mcg/kg dexmedetomidine (group 1) and epidural administration of 0.375% ropivacaine with 8 mg dexamethasone.

Conditions

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Pain, Postoperative Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

epidural administration of dexmedetomidine added to ropivacaine

Dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type DRUG

epidural administration of dexmedetomidine added to ropivacaine

Interventions

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Dexmedetomidine Injection [Precedex]

epidural administration of dexmedetomidine added to ropivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dubrava

OTHER

Sponsor Role lead

Responsible Party

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Jasminka Persec, MD, PhD

Assist Prof MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jasminka Persec, Assit Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Dubrava

Andrej Sribar, MD

Role: STUDY_CHAIR

University Hospital Dubrava

Locations

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Jasminka Persec

Zagreb, , Croatia

Site Status

Countries

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Croatia

Central Contacts

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Jasminka Persec, Assist Prof

Role: CONTACT

+385 1 2902433 ext. +38512902440

Andrej Sribar, MD PhD

Role: CONTACT

+385 1 2902440 ext. +38512902440

Facility Contacts

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Andrej Sribar, MD

Role: primary

+38512902433 ext. +38512902433

Jasminka Persec

Role: backup

+38512902433 ext. +38512902433

References

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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.

Reference Type RESULT
PMID: 28924366 (View on PubMed)

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.

Reference Type RESULT
PMID: 28535549 (View on PubMed)

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.

Reference Type RESULT
PMID: 29325842 (View on PubMed)

Other Identifiers

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UHDubrava777

Identifier Type: -

Identifier Source: org_study_id

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