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Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

Primary Purpose

Pain, Postoperative, Oxidative Stress

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Dexmedetomidine Injection [Precedex]
Sponsored by
University Hospital Dubrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jasminka Persec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmedetomidine

Dexamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

analgesic consumption
analgesic consumption in time interval
oxydative stress level
malonyldialdehyde, glutathion, catalase

Full Information

First Posted
August 8, 2018
Last Updated
August 14, 2018
Sponsor
University Hospital Dubrava
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1. Study Identification

Unique Protocol Identification Number
NCT03632460
Brief Title
Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Oxidative Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
8 mg dexamethasone added to 8 ml 0,375% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Injection [Precedex]
Intervention Description
epidural administration of dexmedetomidine added to ropivacaine
Primary Outcome Measure Information:
Title
Change in postoperative pain level using visual analogue scale
Description
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.
Time Frame
Before operation, 1 hour, 2 hour, 6 hour and 24 hour after operation
Secondary Outcome Measure Information:
Title
analgesic consumption
Description
analgesic consumption in time interval
Time Frame
24 hour
Title
oxydative stress level
Description
malonyldialdehyde, glutathion, catalase
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 allergy coagulation disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jasminka Persec, Assist Prof
Phone
+385 1 2902433
Ext
+38512902440
Email
jasminka@kbd.hr
First Name & Middle Initial & Last Name or Official Title & Degree
Andrej Sribar, MD PhD
Phone
+385 1 2902440
Ext
+38512902440
Email
andrej.sribar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasminka Persec, Assit Prof
Organizational Affiliation
University Hospital Dubrava
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrej Sribar, MD
Organizational Affiliation
University Hospital Dubrava
Official's Role
Study Chair
Facility Information:
Facility Name
Jasminka Persec
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrej Sribar, MD
Phone
+38512902433
Ext
+38512902433
Email
jasminka@kbd.hr
First Name & Middle Initial & Last Name & Degree
Jasminka Persec
Phone
+38512902433
Ext
+38512902433
Email
jasminka@kbd.hr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28924366
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 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.
Results Reference
result
PubMed Identifier
28535549
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.
Results Reference
result
PubMed Identifier
29325842
Citation
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.
Results Reference
result

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Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

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