Mandibular PrognathismPhase 4NCT01634594
The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability
A Phase 4 study testing Group R, Group N and Group D in people with Mandibular Prognathism and Mandibular Retrognathism, run by Yonsei University at 1 site in South Korea.
Trial summary
Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mandibular Prognathism, Mandibular Retrognathism
- What is being tested?
- Group R, Group N and Group D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Feb 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA class 1
- Adults over the age of 20
- Patients requiring deliberate hypotensive anesthesia for orthognathic surgery
Who cannot join
- Patient refusal
- Patients with arrhythmia
- Patients with cardiac anomalies or past history of cardiac surgery
- Patients with abnormal electrolyte levels
- Patients taking medications that are known to prolong QT intervals
- Patients with QTc intervals greater than 440ms
- Illiterate patients
Trial locations and contacts
1 site in 1 country.
About this study
Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several different regimens are used to lower the patient's blood pressure, such as vasodilators, autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the effects that these agents have on the QTc and Tp-e intervals during deliberate hypotension is not known. Virtually every kind of anesthetic is reported to have some effect on the QTc and Tp-e intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the amount of anesthetics and drugs used to maintain low blood pressure is not small. Therefore, the effect that these agents may have on the QTc and Tp-e intervals may not be negligible. The investigators of the present study found that the high dose of commonly used hypotensive agents tend to prolong these variabilities to some extent. This study will be able to provide insight as to which hypotensive anesthesia regimen has the least effect on the QTc and Tp-e intervals, and therefore will be helpful in minimizing cardiovascular risks of deliberate hypotensive anesthesia.
- Conditions
- Mandibular Prognathism, Mandibular Retrognathism
- Being tested
- Group R, Group N, Group D
- Keywords
- Deliberate hypotension, QTc, Tp-e, heart rate variability
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group RDrug
Also called Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC
Group NDrug
Also called Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC
Group DDrug
Also called Continuous infustion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane-remifentanil (group R) | Experimental | Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC Receives: Drug: Group R |
| sevoflurane-nicardipine (group N) | Active comparator | Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC Receives: Drug: Group N |
| sevoflurane-dexmedetomidine (group D) | Active comparator | Continuous infusion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC Receives: Drug: Group D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in QTc, Tp-e interval during deliberate hypotension
Measured: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery
Secondary outcomes (1)
Changes in Tp-e interval during deliberate hypotension
Measured: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular PrognathismStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 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
- NCT01634594
- Sponsor's protocol ID
- 4-2012-0242
- Status last verified
- Mar 2019
- First submitted
- 25 Jun 2012
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability
- ClinicalTrials.gov ID
- NCT01634594
- Acronym / sponsor ID
- 4-2012-0242
- Conditions
- Mandibular Prognathism, Mandibular Retrognathism
- Keywords
- Deliberate hypotension, QTc, Tp-e, heart rate variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 Jul 2012 (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.
Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several different regimens are used to lower the patient's blood pressure, such as vasodilators, autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the effects that these agents have on the QTc and Tp-e intervals during deliberate hypotension is not known. Virtually every kind of anesthetic is reported to have some effect on the QTc and Tp-e intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the amount of anesthetics and drugs used to maintain low blood pressure is not small. Therefore, the effect that these agents may have on the QTc and Tp-e intervals may not be negligible. The investigators of the present study found that the high dose of commonly used hypotensive agents tend to prolong these variabilities to some extent. This study will be able to provide insight as to which hypotensive anesthesia regimen has the least effect on the QTc and Tp-e intervals, and therefore will be helpful in minimizing cardiovascular risks of deliberate hypotensive anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sevoflurane-remifentanil (group R) | Experimental | Drug: Group RContinuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC |
| sevoflurane-nicardipine (group N) | Active comparator | Drug: Group NContinuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC |
| sevoflurane-dexmedetomidine (group D) | Active comparator | Drug: Group DContinuous infusion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class 1
- Adults over the age of 20
- Patients requiring deliberate hypotensive anesthesia for orthognathic surgery
Key exclusion criteria (7 listed)
- Patient refusal
- Patients with arrhythmia
- Patients with cardiac anomalies or past history of cardiac surgery
- Patients with abnormal electrolyte levels
- Patients taking medications that are known to prolong QT intervals
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 |
|---|---|---|
| Group RAlso: Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC | Drug | sevoflurane-remifentanil (group R) |
| Group NAlso: Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC | Drug | sevoflurane-nicardipine (group N) |
| Group DAlso: Continuous infustion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC | Drug | sevoflurane-dexmedetomidine (group D) |
Primary outcome
Changes in QTc, Tp-e interval during deliberate hypotension
Time frame: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery
1 secondary outcome
Changes in Tp-e interval during deliberate hypotension
Time frame: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery
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 19 Mar 2019.
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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 Phase 4 study testing Group R, Group N and Group D in people with Mandibular Prognathism and Mandibular Retrognathism, 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 7 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 19 Mar 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in QTc, Tp-e interval during deliberate hypotension (time frame: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery). 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 19 Mar 2019.