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Norepinephrine Prevent Post-induction Hypotension in High-risk Patients

Primary Purpose

Anesthesia, Blood Pressure, Norepinephrine

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Norepinephrine Hydrochloride
Placebo
Sponsored by
First Affiliated Hospital of Kunming Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring intraoperative hypotension, arterial pressure, general surgery, general anesthesia, noncardiac surgery

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Norepinephrine

    Placebo

    Arm Description

    The interventional group will receive a continuous infusion of norepinephrine 5 minutes (0.01μg/kg*min) before anesthesia induction until skin incision.

    the placebo group will receive a continuous infusion of normal saline (10 ml/h) 5 minutes before anesthesia induction until skin incision.

    Outcomes

    Primary Outcome Measures

    Incidence of post-induction hypotension
    Hypotension: mean arterial pressure (MAP) <65 mmHg

    Secondary Outcome Measures

    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.
    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
    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
    Postoperative major adverse cardiac events
    Cardiac death, myocardial infarction, on-fatal cardiac arrest, coronary revascularization

    Full Information

    First Posted
    August 28, 2023
    Last Updated
    August 31, 2023
    Sponsor
    First Affiliated Hospital of Kunming Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06028256
    Brief Title
    Norepinephrine Prevent Post-induction Hypotension in High-risk Patients
    Official Title
    Continuous Norepinephrine Infusion Before General Anesthesia to Prevent Post-induction Hypotension in High-risk Patients Undergoing Major Noncardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital of Kunming Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, Blood Pressure, Norepinephrine
    Keywords
    intraoperative hypotension, arterial pressure, general surgery, general anesthesia, noncardiac surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Norepinephrine
    Arm Type
    Experimental
    Arm Description
    The interventional group will receive a continuous infusion of norepinephrine 5 minutes (0.01μg/kg*min) before anesthesia induction until skin incision.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    the placebo group will receive a continuous infusion of normal saline (10 ml/h) 5 minutes before anesthesia induction until skin incision.
    Intervention Type
    Drug
    Intervention Name(s)
    Norepinephrine Hydrochloride
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Normal saline will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.
    Primary Outcome Measure Information:
    Title
    Incidence of post-induction hypotension
    Description
    Hypotension: mean arterial pressure (MAP) <65 mmHg
    Time Frame
    From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)
    Secondary Outcome Measure Information:
    Title
    Incidence of the following abnormal vital signs
    Description
    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.
    Time Frame
    From induction of general anesthesia to skin incision (up to one hours from induction of general anesthesia)
    Title
    Incidence of the following abnormal vital signs
    Description
    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
    Time Frame
    From surgical incision to the end of surgery (up to six hours from surgical incision)
    Title
    Incidence of the following abnormal vital signs
    Description
    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
    Time Frame
    from the end of surgery until leaving the post-anesthesia care unit (up to four hours from the end of surgery)
    Title
    Postoperative major adverse cardiac events
    Description
    Cardiac death, myocardial infarction, on-fatal cardiac arrest, coronary revascularization
    Time Frame
    Within 30 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuan Chang
    Phone
    +86 0871 65324888
    Email
    changyuan@ydyy.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jianlin Shao
    Email
    shaojlL@ydyy.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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