Norepinephrine Prevent Post-induction Hypotension in High-risk Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure; Anesthesia; Norepinephrine
• Intervention / Treatment: Drug: Norepinephrine Hydrochloride; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yuan Chang; Phone Number: +86 0871 65324888; Email: changyuan@ydyy.cn
• Study Contact Backup: Name: Jianlin Shao; Email: shaojlL@ydyy.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norepinephrine; The interventional group will receive a continuous infusion of norepinephrine 5 minutes (0.01μg/kg*min) before anesthesia induction until skin incision.	Drug: Norepinephrine Hydrochloride; 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.
Placebo Comparator: Placebo; the placebo group will receive a continuous infusion of normal saline (10 ml/h) 5 minutes before anesthesia induction until skin incision.	Drug: Placebo; Normal saline will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-induction hypotension	Hypotension: mean arterial pressure (MAP) <65 mmHg	From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Kunming Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: general anesthesia; noncardiac surgery; general surgery; intraoperative hypotension; arterial pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: 2023-L-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No