PONVNCT01840254
Effect of Combination Dexmedetomidine Added to Fentanyl-based Intravenous Patient-controlled Analgesia on Nausea Vomiting in Highly Susceptible Patients Undergoing Lumbar Spinal Surgery: Prospective Double Blinded Randomized Controlled Trial
A study testing dexmedetomidine and normal saline in people with PONV, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to test the hypothesis that addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing lumbar spine surgery. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- PONV
- What is being tested?
- dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Sep 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. female, non-smoking patient who are 20-65 of age scheduled for elective lumbar spine surgery
Who cannot join
- Bradycardia on EKG (45bpm)
- Atrioventricular conduction disorder
- Uncontrolled hypertension
- angina history
- obesity (BMI ≥ 30 kg/m2)
- Preoperative administration of opioid
Show all 10Show fewer
- Preoperative administration of antiemetics
- Gastrointestinal disorder history
- Hepatic or renal disease
- Pregnant 11. Foreigner
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
The aim of this study is to test the hypothesis that addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing lumbar spine surgery.
- Conditions
- PONV
- Being tested
- dexmedetomidine, normal saline
- Keywords
- PONV, IV PCA, dexmedetomidine, Female, non-smoking, lumbar spine surgery
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA) Receives: Drug: dexmedetomidine |
| normal saline | Placebo comparator | normal saline as a placebo Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
total dose and bolus administration of opioid
After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased ≥15% after volume expansion. The receiver operating characteristic curve analysis to discriminiate fludi responder is performed.
Measured: an expected average of 48 hrs for requirements of total dose and number of bolus administration of PCA
Secondary outcomes (1)
consequent postoperative nausea and vomiting
After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased ≥15% after volume expansion. The receiver operating characteristic curve analysis to discriminate fluid responder is performed.
Measured: an expected average of 48 hrs for assessing of the 11-points verbal numerical rating scales
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PONVStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 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
- NCT01840254
- Sponsor's protocol ID
- 4-2012-0490
- Status last verified
- Feb 2014
- First submitted
- 17 Apr 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Song Y, Shim JK, Song JW, Kim EK, Kwak YL. Dexmedetomidine added to an opioid-based analgesic regimen for the prevention of postoperative nausea and vomiting in highly susceptible patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):75-83. doi: 10.1097/EJA.0000000000000327.
PubMed 26258655
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combination Dexmedetomidine Added to Fentanyl-based Intravenous Patient-controlled Analgesia on Nausea Vomiting in Highly Susceptible Patients Undergoing Lumbar Spinal Surgery: Prospective Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01840254
- Acronym / sponsor ID
- 4-2012-0490
- Conditions
- PONV
- Keywords
- PONV, IV PCA, dexmedetomidine, Female, non-smoking, lumbar spine surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Apr 2013 (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 is to test the hypothesis that addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing lumbar spine surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: dexmedetomidineaddition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA) |
| normal saline | Placebo comparator | Drug: normal salinenormal saline as a placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. female, non-smoking patient who are 20-65 of age scheduled for elective lumbar spine surgery
Key exclusion criteria (10 listed)
- Bradycardia on EKG (45bpm)
- Atrioventricular conduction disorder
- Uncontrolled hypertension
- angina history
- obesity (BMI ≥ 30 kg/m2)
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 | Drug | dexmedetomidine |
| normal saline | Drug | normal saline |
Primary outcome
total dose and bolus administration of opioid
Time frame: an expected average of 48 hrs for requirements of total dose and number of bolus administration of PCA
After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased ≥15% after volume expansion. The receiver operating characteristic curve analysis to discriminiate fludi responder is performed.
1 secondary outcome
consequent postoperative nausea and vomiting
Time frame: an expected average of 48 hrs for assessing of the 11-points verbal numerical rating scales
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 7 Feb 2014.
- Derived from this study: PubMed 26258655Song Y, Shim JK, Song JW, Kim EK, Kwak YL. Dexmedetomidine added to an opioid-based analgesic regimen for the prevention of postoperative nausea and vomiting in highly susceptible patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):75-83. doi: 10.1097/EJA.0000000000000327.
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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 and normal saline in people with PONV, 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 1 inclusion and 10 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 7 Feb 2014. 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. Some participants in this study may receive a placebo. 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?
total dose and bolus administration of opioid (time frame: an expected average of 48 hrs for requirements of total dose and number of bolus administration of PCA). 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 NCT01840254, which also lists 1 linked publication.
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 7 Feb 2014.