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

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

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Oxidative Stress
• Intervention / Treatment: Drug: Dexmedetomidine Injection [Precedex]

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jasminka Persec, Assist Prof; Phone Number: +38512902440 +385 1 2902433; Email: jasminka@kbd.hr
• Study Contact Backup: Name: Andrej Sribar, MD PhD; Phone Number: +38512902440 +385 1 2902440; Email: andrej.sribar@gmail.com

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Jasminka Persec
    • Contact: Andrej Sribar, MD; Phone Number: +38512902433 +38512902433; Email: jasminka@kbd.hr
    • Contact: Jasminka Persec; Phone Number: +38512902433 +38512902433; Email: jasminka@kbd.hr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine; 1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine	Drug: Dexmedetomidine Injection [Precedex]; epidural administration of dexmedetomidine added to ropivacaine
Active Comparator: Dexamethasone; 8 mg dexamethasone added to 8 ml 0,375% ropivacaine	Drug: Dexmedetomidine Injection [Precedex]; epidural administration of dexmedetomidine added to ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesic consumption	analgesic consumption in time interval	24 hour
oxydative stress level	malonyldialdehyde, glutathion, catalase	24 hour

Collaborators and Investigators

• Sponsor: University Hospital Dubrava
• Investigators: Principal Investigator: Jasminka Persec, Assit Prof, University Hospital Dubrava; Study Chair: Andrej Sribar, MD, University Hospital Dubrava

Publications and helpful links

General Publications

• 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 and fentanyl-based intravenous patient-controlled analgesia. Int J Med Sci. 2017 Aug 18;14(10):951-960. doi: 10.7150/ijms.20347. eCollection 2017.
• 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.
• Gallego-Ligorit L, Vives M, Valles-Torres J, Sanjuan-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 Dec 2.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: UHDubrava777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No