Clinical trial NCT03632460: Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery
Official title: Comparison of Epidural Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine on Postoperative Pain Level, Analgesic Consumption and Oxidative Stress in Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Oxidative Stress
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in postoperative pain level using visual analogue scale
timeFrame: Before operation, 1 hour, 2 hour, 6 hour and 24 hour after operation
Secondary outcomes:
measure: analgesic consumption
timeFrame: 24 hour
measure: oxydative stress level
timeFrame: 24 hour
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Jasminka Persec
Study officials:
affiliation: University Hospital Dubrava
name: Jasminka Persec, Assit Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Dubrava
name: Andrej Sribar, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.