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Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03632460
Enrollment
60
Registered
2018-08-15
Start date
2018-09-01
Completion date
2019-05-01
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress, Pain, Postoperative

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.

Interventions

DRUGDexmedetomidine Injection [Precedex]

epidural administration of dexmedetomidine added to ropivacaine

Sponsors

University Hospital Dubrava
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in postoperative pain level using visual analogue scaleBefore operation, 1 hour, 2 hour, 6 hour and 24 hour after operationChange 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.

Secondary

MeasureTime frameDescription
analgesic consumption24 houranalgesic consumption in time interval
oxydative stress level24 hourmalonyldialdehyde, glutathion, catalase

Countries

Croatia

Contacts

Primary ContactJasminka Persec, Assist Prof
jasminka@kbd.hr+385 1 2902433
Backup ContactAndrej Sribar, MD PhD
andrej.sribar@gmail.com+385 1 2902440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026