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Clinical Trials/NCT03632460
NCT03632460
Unknown
Not Applicable

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

University Hospital Dubrava1 site in 1 country60 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine Injection [Precedex]
Conditions
Pain, Postoperative
Sponsor
University Hospital Dubrava
Enrollment
60
Locations
1
Primary Endpoint
Change in postoperative pain level using visual analogue scale
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
May 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Dubrava
Responsible Party
Principal Investigator
Principal Investigator

Jasminka Persec, MD, PhD

Assist Prof MD PhD

University Hospital Dubrava

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
  • coagulation disorders

Arms & Interventions

Dexmedetomidine

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

Intervention: Dexmedetomidine Injection [Precedex]

Dexamethasone

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

Intervention: Dexmedetomidine Injection [Precedex]

Outcomes

Primary Outcomes

Change in postoperative pain level using visual analogue scale

Time Frame: Before operation, 1 hour, 2 hour, 6 hour and 24 hour after operation

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.

Secondary Outcomes

  • oxydative stress level(24 hour)
  • analgesic consumption(24 hour)

Study Sites (1)

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