Hypotension, ControlledNCT02001298
Remifentanil and Nitroprusside for Controlled Hypotension
A study testing remifentanil and nitroprusside in people with Hypotension, Controlled, run by Jeju National University School of Medicine at 1 site in South Korea.
Trial summary
The purpose of this study is the comparison of the cardiovascular effects of remifentanil and nitroprusside for controlled hypotension Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hypotension, Controlled
- What is being tested?
- remifentanil and nitroprusside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who underwent endoscopic sinus surgery
Who cannot join
- patient who took any drug to influence this study
- patient with cardiovascular disease, renal disease or liver disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jeju National University Hospital
Jeju City, Jeju Special Self-Governing Province, 690-767
About this study
Official title: The Comparison of the Cardiovascular Effects of Remifentanil and Nitroprusside for Controlled Hypotension
The purpose of this study is the comparison of the cardiovascular effects of remifentanil and nitroprusside for controlled hypotension
- Conditions
- Hypotension, Controlled
- Being tested
- remifentanil, nitroprusside
- Keywords
- remifentanil, nitroprusside, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
nitroprussideDrug
| Study group | Role | What they receive |
|---|---|---|
| nitroprusside | Experimental | After induction of anesthesia, controlled hypotension was induced with continuous infusion of nitroprusside. Cardiac index, stroke volume index, and total peripheral resistance index were continuously measured using noninvasive cardiac output monitor (Cheetah NICOM, Cheetah Medical Inc, UK). Receives: Drug: nitroprusside |
| remifentanil | Experimental | After induction of anesthesia, controlled hypotension was induced with continuous infusion of remifentanil. Cardiac index, stroke volume index, and total peripheral resistance index were continuously measured using noninvasive cardiac output monitor (Cheetah NICOM, Cheetah Medical Inc, UK). Receives: Drug: remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac index
Cardiac index was continuously measured during controlled hypotension using noninvasive cardiac output monitor. The average of cardiac index during controlled hypotension was compared with baseline value.
Measured: Cardiac index was continuously measured during controlled hypotension, an average of 90 min
Secondary outcomes (1)
Total peripheral resistance index
Total peripheral resistance index was continuously measured during controlled hypotension using noninvasive cardiac output monitor. The average of total peripheral resistance index during controlled hypotension was compared with baseline value.
Measured: Total peripheral resistance index was continuously measured during controlled hypotension, an average of 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJun 2012
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension, ControlledStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeju National University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jung Kim, Jeju National University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001298
- Sponsor's protocol ID
- HJKim3
- Status last verified
- Nov 2013
- First submitted
- 24 Nov 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Cardiovascular Effects of Remifentanil and Nitroprusside for Controlled Hypotension
- ClinicalTrials.gov ID
- NCT02001298
- Acronym / sponsor ID
- HJKim3
- Conditions
- Hypotension, Controlled
- Keywords
- remifentanil, nitroprusside, hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jeju National University School of MedicineUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (actual)
- First posted
- 4 Dec 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 purpose of this study is the comparison of the cardiovascular effects of remifentanil and nitroprusside for controlled hypotension
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nitroprusside | Experimental | Drug: nitroprussideAfter induction of anesthesia, controlled hypotension was induced with continuous infusion of nitroprusside. Cardiac index, stroke volume index, and total peripheral resistance index were continuously measured using noninvasive cardiac output monitor (Cheetah NICOM, Cheetah Medical Inc, UK). |
| remifentanil | Experimental | Drug: remifentanilAfter induction of anesthesia, controlled hypotension was induced with continuous infusion of remifentanil. Cardiac index, stroke volume index, and total peripheral resistance index were continuously measured using noninvasive cardiac output monitor (Cheetah NICOM, Cheetah Medical Inc, UK). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who underwent endoscopic sinus surgery
Key exclusion criteria (2 listed)
- patient who took any drug to influence this study
- patient with cardiovascular disease, renal disease or liver disease
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 |
|---|---|---|
| remifentanil | Drug | remifentanil |
| nitroprusside | Drug | nitroprusside |
Primary outcome
Cardiac index
Time frame: Cardiac index was continuously measured during controlled hypotension, an average of 90 min
Cardiac index was continuously measured during controlled hypotension using noninvasive cardiac output monitor. The average of cardiac index during controlled hypotension was compared with baseline value.
1 secondary outcome
Total peripheral resistance index
Time frame: Total peripheral resistance index was continuously measured during controlled hypotension, an average of 90 min
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 4 Dec 2013.
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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 remifentanil and nitroprusside in people with Hypotension, Controlled, run by Jeju National University School of Medicine 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 2 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 4 Dec 2013. 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?
Cardiac index (time frame: Cardiac index was continuously measured during controlled hypotension, an average of 90 min). 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 4 Dec 2013.