Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery

Norepinephrine Clinical Trial

Official title:

Second Affiliated Hosptial， School of Medicine, ZheJiang University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637164
• Other study ID #: 2022-0950
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: November 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Yan, Doctor
• Phone: 13757118632
• Email: zryanmin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to determine the ED50 and ED95 of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients undergoing major abdominal surgery using up-and-down sequential method . The main question it aims to answer is: What is the effective concentration of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients. Participants will receive different concentrations of norepinephrine infusion at the beginning of anesthesia induction until 15 minutes after intubation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• aged 65 to 80 years
• Undergoing major abdominal surgery
• American Society of Anesthesiologists (ASA) physical status of I/II/III

Exclusion Criteria:

• Patient refusal
• Severe untreated or uncontrolled hypertension despite medications
• Bradycardia (heart rate < 50 beat per minute)
• Cardiac morbidities, heart block greater than the first degree
• Severe hepatic and renal dysfunction
• hyperthyroidism
• vascular diseases
• BMI>30
• Monoamine oxidase inhibitors were used 2 weeks before surgery

Related Conditions & MeSH terms

• Hypotension
• Post-induction Hypotension

Intervention

Drug:
• norepinephrine bitartrate
The treatment group will receive a continuous infusion of norepinephrine at the beginning of anesthesia induction until 15 minutes after intubation. The dosage of norepinephrine was decided by the up-and-down sequential allocation method with an initial dose of 0.05 µg/kg/min and a 0.005 µg/kg/min gradient.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypotension	less than 80% baseline blood pressure less than 80% baseline blood pressure less than 80% baseline blood pressure	15 minutes after intubation
Secondary	incidence of bradycardia	heart rate less than 50 beat per minute	15 minutes after intubation
Secondary	incidence of reactive hypertension	increased mean arterial pressure by > 20% of the baseline reading	15 minutes after intubation