Norepinephrine Prevent Post-induction Hypotension in High-risk Patients

Anesthesia Clinical Trial

Official title:

Continuous Norepinephrine Infusion Before General Anesthesia to Prevent Post-induction Hypotension in High-risk Patients Undergoing Major Noncardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06028256
• Other study ID #: 2023-L-126
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: August 2023
• Source: First Affiliated Hospital of Kunming Medical University
• Contact: Yuan Chang
• Phone: +86 0871 65324888
• Email: changyuan[@]ydyy.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Blood Pressure
• Hypotension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Kunming Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Postoperative major adverse cardiac events	Cardiac death, myocardial infarction, on-fatal cardiac arrest, coronary revascularization	Within 30 days after surgery