CardiovascularNCT04121416
Comparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery
A study testing Oxycodone 10mg and Sufentanil in people with Cardiovascular, run by Shengjing Hospital at 1 site in China.
Trial summary
To evaluate the effect of oxycodone and sufentanil in preventing cardiovascular responses to tracheal intubation in the patients with coronary heart disease (CHD). Read more about this study
- Who is it for?
- Ages 60 to 85 years, women only
- Conditions the study is for
- Cardiovascular
- What is being tested?
- Oxycodone 10mg and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 19 Sep 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 60 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The coronary angiography from each patient showed that lesions exist in at least one main coronary artery
Who cannot join
- a history of reactive airway disease, gastroesophageal reflux, morbid obesity, a known or predicted difficult airway
Trial locations and contacts
1 site in 1 country.
China1 site
shengjing hospital of China medical university
Shenyang, Liaoning, 110004
About this study
To evaluate the effect of oxycodone and sufentanil in preventing cardiovascular responses to tracheal intubation in the patients with coronary heart disease (CHD).
Read the detailed description
Laryngoscopy and tracheal intubation can provoke an increase of blood pressure (BP) and/or HR [1.2]. This hemodynamic stress may lead to an imbalance between myocardial oxygen consumption and supply and therefore induce myocardial ischemia, which may be endurable in the patients with normal cardiovascular condition but is potential harmful to the patients with coronary heart disease. Thus it is critical to attenuate the cardiovascular stress induced by laryngoscopy and endotracheal intubation in the high risk patients.
- Conditions
- Cardiovascular
- Being tested
- Oxycodone 10mg, Sufentanil
- Keywords
- Oxycodone, Sufentanil, tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone 10mgDrug
induction with 0.3mg/kg of oxycodone in general anesthesia
SufentanilDrug
induction with 0.3 µg/kg of Sufentanil in general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone group | Experimental | Not described Receives: Drug: Oxycodone 10mg |
| Sufentanil group | Experimental | Not described Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure(SBP)、diastolic blood pressure(DBP)、mean arterial pressure(MAP)
Under local anesthesia invasive artery line was put to the patients to monitor systolic blood pressure(SBP)、diastolic blood pressure(DBP)、mean arterial pressure(MAP)
Measured: one second before anesthesia induction, the moment when tracheal catheter passes through glottis and at 1, 3, 5 min after tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Apr 2019
- Primary completion31 Aug 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- Junchao Zhu, Study director, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121416
- Sponsor's protocol ID
- Oxycodone VS Sufentanil
- Status last verified
- Apr 2019
- First submitted
- 2 Oct 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT04121416
- Acronym / sponsor ID
- Oxycodone VS Sufentanil
- Conditions
- Cardiovascular
- Keywords
- Oxycodone, Sufentanil, tracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 9 Oct 2019 (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.
To evaluate the effect of oxycodone and sufentanil in preventing cardiovascular responses to tracheal intubation in the patients with coronary heart disease (CHD).
Detailed description
Laryngoscopy and tracheal intubation can provoke an increase of blood pressure (BP) and/or HR [1.2]. This hemodynamic stress may lead to an imbalance between myocardial oxygen consumption and supply and therefore induce myocardial ischemia, which may be endurable in the patients with normal cardiovascular condition but is potential harmful to the patients with coronary heart disease. Thus it is critical to attenuate the cardiovascular stress induced by laryngoscopy and endotracheal intubation in the high risk patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone group | Experimental | Drug: Oxycodone 10mg |
| Sufentanil group | Experimental | Drug: Sufentanil |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The coronary angiography from each patient showed that lesions exist in at least one main coronary artery
Key exclusion criteria (1 listed)
- a history of reactive airway disease, gastroesophageal reflux, morbid obesity, a known or predicted difficult airway
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 |
|---|---|---|
| Oxycodone 10mginduction with 0.3mg/kg of oxycodone in general anesthesia | Drug | Oxycodone group |
| Sufentanilinduction with 0.3 µg/kg of Sufentanil in general anesthesia | Drug | Sufentanil group |
Primary outcome
blood pressure(SBP)、diastolic blood pressure(DBP)、mean arterial pressure(MAP)
Time frame: one second before anesthesia induction, the moment when tracheal catheter passes through glottis and at 1, 3, 5 min after tracheal intubation
Under local anesthesia invasive artery line was put to the patients to monitor systolic blood pressure(SBP)、diastolic blood pressure(DBP)、mean arterial pressure(MAP)
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 9 Oct 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.
Junchao Zhu study director
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone 10mg and Sufentanil in people with Cardiovascular, run by Shengjing Hospital at 1 site in China.
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 1 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 9 Oct 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 China. 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?
blood pressure(SBP)、diastolic blood pressure(DBP)、mean arterial pressure(MAP) (time frame: one second before anesthesia induction, the moment when tracheal catheter passes through glottis and at 1, 3, 5 min after tracheal intubation). 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 9 Oct 2019.