AnesthesiaPhase 4NCT06028256
Norepinephrine Prevent Post-induction Hypotension in High-risk Patients
A Phase 4 study testing Norepinephrine Hydrochloride in people with Anesthesia and Blood Pressure, run by First Affiliated Hospital of Kunming Medical University.
Trial summary
The investigators aimed to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Anesthesia, Blood Pressure, Norepinephrine
- What is being tested?
- Norepinephrine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Oct 2024
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged above 65 years or those above 45 years with at least one of the following preoperative cardiovascular diseases: essential hypertension, coronary artery disease, stroke, or type I/II diabetes mellitus.
- Patients who will receive major noncardiac surgery as open or laparoscopic abdominal surgeries with an anticipated operative duration over two hours, including gastrointestinal, liver, pancreatic, bladder, and uterine/adnexal surgeries.
Who cannot join
- Patients who declined to participate in the present study.
- Patients enrolled in another ongoing clinical study.
- Patients with systolic arterial pressure (SAP) below 90 mmHg or above 160 mmHg, or heart rate (HR) over 100 beats per minute (bpm) before anesthesia induction.
- Patients who have experienced any type of shock within 30 days before surgery.
- Patients with circulatory instability require continuous or intermittent positive inotropic and/or vasopressors within 24 hours before surgery.
- Patients receive continuous or intermittent intravenous antihypertensive agents within 24 hours before surgery.
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- Patients underwent coronary artery bypass grafting, coronary angiography, or coronary stenting within 180 days before surgery.
- Patients who were diagnosed with new-onset tachyarrhythmia within 180 days before surgery, such as atrial fibrillation, atrial flutter, and premature ventricular contractions.
- Patients with preoperative alanine aminotransferase >80 international units and/or glomerular filtration rate < 80 ml/min within the 180 days before surgery.
- Patients are ineligible for intraoperative invasive radial artery blood pressure monitoring.
- Patients with a known history of allergy to norepinephrine.
- Patients who were planned for rapid sequence induction.
- Patients who were scheduled for awake tracheal intubation.
- Patients who were scheduled for double-lumen endotracheal intubation. Pregnant or lactating patients.
Trial locations and contacts
No sites are listed yet.
Jianlin Shao contact
About this study
Official title: Continuous Norepinephrine Infusion Before General Anesthesia to Prevent Post-induction Hypotension in High-risk Patients Undergoing Major Noncardiac Surgery
The investigators aimed to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension.
Read the detailed description
Intraoperative hypotension is common after general anesthesia induction and is associated with adverse postoperative events. Norepinephrine is one of the most applied vasopressors in clinical to treat intraoperative hypotension. Due to the absence of effective measures for predicting intraoperative hypotension, infusing norepinephrine before and during anesthesia induction may reduce intraoperative hypotension. There is currently a lack of research regarding whether continuous norepinephrine infusion before and during the induction of general anesthesia can mitigate or prevent post-induction hypotension. The investigators aim to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension.
- Conditions
- Anesthesia, Blood Pressure, Norepinephrine
- Being tested
- Norepinephrine Hydrochloride, Placebo
- Keywords
- intraoperative hypotension, arterial pressure, general surgery, general anesthesia, noncardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine HydrochlorideDrug
Both arms of patients will receive standard anesthesia and surgical management. Radial artery cannulation and invasive blood pressure monitoring will be perform.
Norepinephrine will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.
PlaceboDrug
Normal saline will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine | Experimental | The interventional group will receive a continuous infusion of norepinephrine 5 minutes (0.01μg/kg*min) before anesthesia induction until skin incision. Receives: Drug: Norepinephrine Hydrochloride |
| Placebo | Placebo comparator | the placebo group will receive a continuous infusion of normal saline (10 ml/h) 5 minutes before anesthesia induction until skin incision. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-induction hypotension
Hypotension: mean arterial pressure (MAP) <65 mmHg
Measured: From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)
Secondary outcomes (4)
Incidence of the following abnormal vital signs
MAP<65 mmHg, MAP<55 mmHg, MAP decreased over 20% ,30% and 40% from preoperative level; MAP increased over 20%, 30%, and 40% from preoperative level; SAP < 90 mmHg; Systolic arterial pressure (SAP) > 160 mmHg; Heart rate (HR) < 40 bpm, HR > 100 bpm; dosage of norepinephrine given by anesthesiologists; amount of fluid; the time-point of the first events of MAP < 65 mmHg, MAP < 55 mmHg, SAP < 90 mmHg, SAP > 160 mmHg, MAP increased over 20%, 30%, and 40% from preoperative level.
Measured: From induction of general anesthesia to skin incision (up to one hours from induction of general anesthesia)
Incidence of the following abnormal vital signs
MAP<65 mmHg, MAP<55 mmHg, MAP decreased over 20%, 30%, and 40% from preoperative level; MAP increased over 20%, 30%, and 40% from preoperative level; SAP < 90 mmHg; SAP > 160 mmHg; HR < 40 bpm, HR > 100 bpm. Dosage of norepinephrine given by anesthesiologists; amount of fluid; the time-point of the first events of MAP < 65 mmHg, MAP < 55 mmHg, SAP < 90 mmHg, SAP > 160 mmHg, MAP increased over 20%, 30%, and 40% from preoperative level
Measured: From surgical incision to the end of surgery (up to six hours from surgical incision)
Incidence of the following abnormal vital signs
MAP<65 mmHg, MAP<55 mmHg, MAP decreased over 20%, 30%, and 40% from preoperative level; MAP increased over 20%, 30%, and 40% from preoperative level; SAP < 90 mmHg; SAP > 160 mmHg; HR < 40 bpm, HR > 100 bpm. Dosage of norepinephrine given by anesthesiologists; amount of fluid; the time-point of the first events of MAP < 65 mmHg, MAP < 55 mmHg, SAP < 90 mmHg, SAP > 160 mmHg, MAP increased over 20%, 30%, and 40% from preoperative level
Measured: from the end of surgery until leaving the post-anesthesia care unit (up to four hours from the end of surgery)
Postoperative major adverse cardiac events
Cardiac death, myocardial infarction, on-fatal cardiac arrest, coronary revascularization
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Chang, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028256
- Sponsor's protocol ID
- 2023-L-126
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Norepinephrine Infusion Before General Anesthesia to Prevent Post-induction Hypotension in High-risk Patients Undergoing Major Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT06028256
- Acronym / sponsor ID
- 2023-L-126
- Conditions
- Anesthesia, Blood Pressure, Norepinephrine
- Keywords
- intraoperative hypotension, arterial pressure, general surgery, general anesthesia, noncardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 8 Sep 2023 (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.
The investigators aimed to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension.
Detailed description
Intraoperative hypotension is common after general anesthesia induction and is associated with adverse postoperative events. Norepinephrine is one of the most applied vasopressors in clinical to treat intraoperative hypotension. Due to the absence of effective measures for predicting intraoperative hypotension, infusing norepinephrine before and during anesthesia induction may reduce intraoperative hypotension. There is currently a lack of research regarding whether continuous norepinephrine infusion before and during the induction of general anesthesia can mitigate or prevent post-induction hypotension. The investigators aim to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine | Experimental | Drug: Norepinephrine HydrochlorideThe interventional group will receive a continuous infusion of norepinephrine 5 minutes (0.01μg/kg*min) before anesthesia induction until skin incision. |
| Placebo | Placebo comparator | Drug: Placebothe placebo group will receive a continuous infusion of normal saline (10 ml/h) 5 minutes before anesthesia induction until skin incision. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged above 65 years or those above 45 years with at least one of the following preoperative cardiovascular diseases: essential hypertension, coronary artery disease, stroke, or type I/II diabetes mellitus.
- Patients who will receive major noncardiac surgery as open or laparoscopic abdominal surgeries with an anticipated operative duration over two hours, including gastrointestinal, liver, pancreatic, bladder, and uterine/adnexal surgeries.
Key exclusion criteria (14 listed)
- Patients who declined to participate in the present study.
- Patients enrolled in another ongoing clinical study.
- Patients with systolic arterial pressure (SAP) below 90 mmHg or above 160 mmHg, or heart rate (HR) over 100 beats per minute (bpm) before anesthesia induction.
- Patients who have experienced any type of shock within 30 days before surgery.
- Patients with circulatory instability require continuous or intermittent positive inotropic and/or vasopressors within 24 hours before surgery.
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 |
|---|---|---|
| Norepinephrine HydrochlorideBoth arms of patients will receive standard anesthesia and surgical management. Radial artery cannulation and invasive blood pressure monitoring will be perform. Norepinephrine will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision. | Drug | Norepinephrine |
| PlaceboNormal saline will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision. | Drug | Placebo |
Primary outcome
Incidence of post-induction hypotension
Time frame: From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)
Hypotension: mean arterial pressure (MAP) <65 mmHg
4 secondary outcomes
Incidence of the following abnormal vital signs
Time frame: From induction of general anesthesia to skin incision (up to one hours from induction of general anesthesia)
Incidence of the following abnormal vital signs
Time frame: From surgical incision to the end of surgery (up to six hours from surgical incision)
Incidence of the following abnormal vital signs
Time frame: from the end of surgery until leaving the post-anesthesia care unit (up to four hours from the end of surgery)
Postoperative major adverse cardiac events
Time frame: Within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Jianlin Shao contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine Hydrochloride in people with Anesthesia and Blood Pressure, run by First Affiliated Hospital of Kunming Medical University.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Chang (+86 0871 65324888, changyuan@ydyy.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-induction hypotension (time frame: From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)). 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 8 Sep 2023.