Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03632460
• Other study ID #: UHDubrava777
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: August 2018
• Source: University Hospital Dubrava
• Contact: Jasminka Persec, Assist Prof
• Phone: +385 1 2902433
• Email: jasminka[@]kbd.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxidative Stress
• Pain, Postoperative

Intervention

Drug:
• Dexmedetomidine Injection [Precedex]
epidural administration of dexmedetomidine added to ropivacaine

Locations

Country	Name	City	State
Croatia	Jasminka Persec	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

References & Publications (3)

Gallego-Ligorit L, Vives M, Vallés-Torres J, Sanjuán-Villarreal TA, Pajares A, Iglesias M. Use of Dexmedetomidine in Cardiothoracic and Vascular Anesthesia. J Cardiothorac Vasc Anesth. 2018 Jun;32(3):1426-1438. doi: 10.1053/j.jvca.2017.11.044. Epub 2017 D — View Citation

Hong JM, Kim KH, Lee HJ, Kwon JY, Kim HK, Kim HJ, Cho AR, Do WS, Kim HS. Epidural Dexamethasone Influences Postoperative Analgesia after Major Abdominal Surgery. Pain Physician. 2017 May;20(4):261-269. — View Citation

Kim NY, Kwon TD, Bai SJ, Noh SH, Hong JH, Lee H, Lee KY. Effects of dexmedetomidine in combination with fentanyl-based intravenous patient-controlled analgesia on pain attenuation after open gastrectomy in comparison with conventional thoracic epidural an — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	analgesic consumption	analgesic consumption in time interval	24 hour
Secondary	oxydative stress level	malonyldialdehyde, glutathion, catalase	24 hour