Postoperative PainNCT02325882
The Postoperative Analgesic Effect of Combination With Dexmedetomidine in Fentanyl-based Intravenous Patient Controlled Analgesia Compared With Conventional Thoracic Epidural and Intravenous Patient Controlled Analgesia After Radical Open Gastrectomy
A study testing Dexmedetomidine, Fentanyl 1 and Fentanyl 2 in people with Postoperative Pain, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based intravenous patient controlled analgesia (PCA) improves postoperative pain compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexmedetomidine, Fentanyl 1 and Fentanyl 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Mar 2016
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA class I-II
- obtaining written informed consent from the parents
- aged 20-65 years who were undergoing radical open gastrectomy
Who cannot join
- abdominal surgery previously
- patient who refuse the patient controlled analgesia
- unstable angina or congestive heart failure
- uncontrolled hypertension (diastolic bp>110mmHg)
- coagulopathy
- hepatic failure
Show all 14Show fewer
- renal failure
- bradycardia on EKG (under 50 bpm)
- Ventricular conduction abnormality
- drug hyperactivity
- neurological or psychiatric illnesses
- mental retardation
- patients who can't read the consent form due to illiterate or foreigner 14.infection
- 15. pregnant 16. obesity (BMI > 30kg/m2)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Seoul, 120-752
About this study
The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based intravenous patient controlled analgesia (PCA) improves postoperative pain compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy.
- Conditions
- Postoperative Pain
- Being tested
- Dexmedetomidine, Fentanyl 1, Fentanyl 2
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine mixed fentanyl based intravenous PCA
Fentanyl 1Drug
conventional fentanyl-based epidural PCA
Fentanyl 2Drug
conventional fentanyl based intravenous PCA
| Study group | Role | What they receive |
|---|---|---|
| Conventional fentanyl-based epidural PCA | Active comparator | Not described Receives: Drug: Fentanyl 1 |
| dexmedetomidine to fentanyl-based intravenous PCA | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Conventional fentanyl-based intravenous PCA | Active comparator | Not described Receives: Drug: Fentanyl 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs
Measured: 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325882
- Sponsor's protocol ID
- 4-2014-0883
- Status last verified
- Mar 2016
- First submitted
- 21 Dec 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postoperative Analgesic Effect of Combination With Dexmedetomidine in Fentanyl-based Intravenous Patient Controlled Analgesia Compared With Conventional Thoracic Epidural and Intravenous Patient Controlled Analgesia After Radical Open Gastrectomy
- ClinicalTrials.gov ID
- NCT02325882
- Acronym / sponsor ID
- 4-2014-0883
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Dec 2014 (estimated)
- 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 this study to test hypothesis that addition of dexmedetomidine to fentanyl based intravenous patient controlled analgesia (PCA) improves postoperative pain compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional fentanyl-based epidural PCA | Active comparator | Drug: Fentanyl 1 |
| dexmedetomidine to fentanyl-based intravenous PCA | Experimental | Drug: Dexmedetomidine |
| Conventional fentanyl-based intravenous PCA | Active comparator | Drug: Fentanyl 2 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class I-II
- obtaining written informed consent from the parents
- aged 20-65 years who were undergoing radical open gastrectomy
Key exclusion criteria (14 listed)
- abdominal surgery previously
- patient who refuse the patient controlled analgesia
- unstable angina or congestive heart failure
- uncontrolled hypertension (diastolic bp>110mmHg)
- coagulopathy
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine mixed fentanyl based intravenous PCA | Drug | dexmedetomidine to fentanyl-based intravenous PCA |
| Fentanyl 1conventional fentanyl-based epidural PCA | Drug | Conventional fentanyl-based epidural PCA |
| Fentanyl 2conventional fentanyl based intravenous PCA | Drug | Conventional fentanyl-based intravenous PCA |
Primary outcome
Postoperative pain
Time frame: 48 hours after operation
Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Fentanyl 1 and Fentanyl 2 in people with Postoperative Pain, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 29 Mar 2016. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 48 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2016.