Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

Study Overview
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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.

Official Title
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Comparison of Epidural Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine on Postoperative Pain Level, Analgesic Consumption and Oxidative Stress in Thoracic Surgery

Conditions
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Pain, Postoperative, Oxidative Stress

Intervention / Treatment
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* Drug: Dexmedetomidine Injection [Precedex]


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine | Drug: Dexmedetomidine Injection [Precedex]<br>* epidural administration of dexmedetomidine added to ropivacaine<br>|
| Active Comparator: Dexamethasone<br>8 mg dexamethasone added to 8 ml 0,375% ropivacaine | Drug: Dexmedetomidine Injection [Precedex]<br>* epidural administration of dexmedetomidine added to ropivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption | analgesic consumption in time interval | 24 hour | 
| oxydative stress level | malonyldialdehyde, glutathion, catalase | 24 hour |