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

Primary Purpose

Norepinephrine, Post-induction Hypotension

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

norepinephrine bitartrate

About this trial

This is an interventional prevention trial for Norepinephrine

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Second Affiliated Hospital of Zhejiang University Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Norepinephrine

Arm Description

Outcomes

Primary Outcome Measures

Incidence of hypotension

less than 80% baseline blood pressure less than 80% baseline blood pressure less than 80% baseline blood pressure

Secondary Outcome Measures

incidence of bradycardia

heart rate less than 50 beat per minute

incidence of reactive hypertension

increased mean arterial pressure by > 20% of the baseline reading

Full Information

NCT ID

NCT05637164

First Posted

November 28, 2022

Last Updated

November 28, 2022

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05637164

Brief Title

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

Official Title

Second Affiliated Hosptial， School of Medicine, ZheJiang University

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Anticipated)

Primary Completion Date

May 30, 2023 (Anticipated)

Study Completion Date

May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Norepinephrine, Post-induction Hypotension

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Norepinephrine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

norepinephrine bitartrate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of hypotension

Description

less than 80% baseline blood pressure less than 80% baseline blood pressure less than 80% baseline blood pressure

Time Frame

15 minutes after intubation

Secondary Outcome Measure Information:

Title

incidence of bradycardia

Description

heart rate less than 50 beat per minute

Time Frame

15 minutes after intubation

Title

incidence of reactive hypertension

Description

increased mean arterial pressure by > 20% of the baseline reading

Time Frame

15 minutes after intubation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Min Yan, Doctor

Phone

13757118632

zryanmin@zju.edu.cn

Facility Information:

Facility Name

The Second Affiliated Hospital of Zhejiang University Medical College

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Min Yan, Doctor

Phone

13757118632

zryanmin@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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