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

November 28, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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