Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

U

University Hospital Dubrava

Status

Unknown

Conditions

Pain, Postoperative
Oxidative Stress

Treatments

Drug: Dexmedetomidine Injection [Precedex]

Study type

Interventional

Funder types

Other

Identifiers

NCT03632460
UHDubrava777

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Dexmedetomidine
Active Comparator group
Description:
1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine
Treatment:
Drug: Dexmedetomidine Injection [Precedex]
Dexamethasone
Active Comparator group
Description:
8 mg dexamethasone added to 8 ml 0,375% ropivacaine
Treatment:
Drug: Dexmedetomidine Injection [Precedex]

Trial contacts and locations

1

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Central trial contact

Andrej Sribar, MD PhD; Jasminka Persec, Assist Prof

Data sourced from clinicaltrials.gov

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