Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

Not Applicable

• Conditions: Pain, Postoperative; Oxidative Stress
• Interventions: Drug: Dexmedetomidine Injection [Precedex]

• Registration Number: NCT03632460
• Lead Sponsor: University Hospital Dubrava

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.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-14
• Last Update Submitted: 2018-08-14
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Study Start: 2018-09-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexmedetomidine Injection [Precedex]	8 mg dexamethasone added to 8 ml 0,375% ropivacaine
Dexmedetomidine	Dexmedetomidine Injection [Precedex]	1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine

Primary Outcome Measures

Name	Time	Method
Change in postoperative pain level using visual analogue scale	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 Outcome Measures

Name	Time	Method
analgesic consumption	24 hour	analgesic consumption in time interval
oxydative stress level	24 hour	malonyldialdehyde, glutathion, catalase

Trial Locations

Locations (1)

Jasminka Persec; 🇭🇷 Zagreb, Croatia