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

Second Affiliated Hosptial， School of Medicine, ZheJiang University

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.

Study Overview

• Status: Recruiting
• Conditions: Norepinephrine; Post-induction Hypotension
• Intervention / Treatment: Drug: norepinephrine bitartrate

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years to 76 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norepinephrine	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of bradycardia	heart rate less than 50 beat per minute	15 minutes after intubation
incidence of reactive hypertension	increased mean arterial pressure by > 20% of the baseline reading	15 minutes after intubation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• 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: 2022-0950

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