Norepinephrine Prevent Post-induction Hypotension in High-risk Patients

NCT06028256 | Unknown Phase 4

• 1 other identifier: 2023-L-126
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia; Blood Pressure; Norepinephrine

Keywords

intraoperative hypotension; arterial pressure; general surgery; general anesthesia; noncardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of the following abnormal vital signs

  From induction of general anesthesia to skin incision (up to one hours from induction of general anesthesia)

• Incidence of the following abnormal vital signs

  From surgical incision to the end of surgery (up to six hours from surgical incision)

• Incidence of the following abnormal vital signs

  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

  Within 30 days after surgery

Study Arms (2)

Norepinephrine

EXPERIMENTAL

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

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.

Drug: Placebo

Interventions

Norepinephrine Hydrochloride DRUG

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.

Norepinephrine

Placebo DRUG

Normal saline will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Yuan Chang

CONTACT

+86 0871 65324888; changyuan@ydyy.cn

Jianlin Shao

CONTACT

shaojlL@ydyy.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 8, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share