Pain, PostoperativeNCT03632460
Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery
A study testing Dexmedetomidine Injection [Precedex] in people with Pain, Postoperative and Oxidative Stress, run by University Hospital Dubrava at 1 site in Croatia.
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 Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pain, Postoperative, Oxidative Stress
- What is being tested?
- Dexmedetomidine Injection [Precedex]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing thoracic surgery due to malignant process of lung or oesophagus ASA (American Society of Anesthesiologists) status I-III
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Croatia1 site
Jasminka Persec
Zagreb, 10000
Andrej Sribar, MD, +38512902433 ext. +38512902433, jasminka@kbd.hr
Jasminka Persec, +38512902433 ext. +38512902433, jasminka@kbd.hr
About this study
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
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
Read the 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.
- Conditions
- Pain, Postoperative, Oxidative Stress
- Being tested
- Dexmedetomidine Injection [Precedex]
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injection [Precedex]Drug
epidural administration of dexmedetomidine added to ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | 1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine Receives: Drug: Dexmedetomidine Injection [Precedex] |
| Dexamethasone | Active comparator | 8 mg dexamethasone added to 8 ml 0,375% ropivacaine Receives: Drug: Dexmedetomidine Injection [Precedex] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before operation, 1 hour, 2 hour, 6 hour and 24 hour after operation
Secondary outcomes (2)
analgesic consumption
analgesic consumption in time interval
Measured: 24 hour
oxydative stress level
malonyldialdehyde, glutathion, catalase
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasminka Persec, MD, PhD, University Hospital Dubrava
- Investigators
- Jasminka Persec, Assit Prof, Principal investigator, University Hospital DubravaAndrej Sribar, MD, Study chair, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632460
- Sponsor's protocol ID
- UHDubrava777
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28924366Hong 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.
PubMed 28535549Gallego-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.
PubMed 29325842
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03632460
- Acronym / sponsor ID
- UHDubrava777
- Conditions
- Pain, Postoperative, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine Injection [Precedex]1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine |
| Dexamethasone | Active comparator | Drug: Dexmedetomidine Injection [Precedex]8 mg dexamethasone added to 8 ml 0,375% ropivacaine |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing thoracic surgery due to malignant process of lung or oesophagus ASA (American Society of Anesthesiologists) status I-III
Key exclusion criteria (8 listed)
- neurological or psychiatric disease
- corticosteroid therapy
- anamnesis of myocardial infarct within last 6 months
- severe aortic stenosis
- kidney insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine Injection [Precedex]epidural administration of dexmedetomidine added to ropivacaine | Drug | Dexamethasone, Dexmedetomidine |
Primary outcome
Change in postoperative pain level using visual analogue scale
Time frame: 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.
2 secondary outcomes
analgesic consumption
Time frame: 24 hour
oxydative stress level
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Results publication: PubMed 28924366Kim 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 publication: PubMed 28535549Hong 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 publication: PubMed 29325842Gallego-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.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasminka Persec, Assit Prof principal investigator
University Hospital Dubrava
Andrej Sribar, MD study chair
University Hospital Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine Injection [Precedex] in people with Pain, Postoperative and Oxidative Stress, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasminka Persec, Assist Prof (+385 1 2902433 ext. +38512902440, jasminka@kbd.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative pain level using visual analogue scale (time frame: Before operation, 1 hour, 2 hour, 6 hour and 24 hour after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03632460, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.