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

NCT05637164 | Unknown

• 1 other identifier: 2022-0950
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Norepinephrine; Post-induction Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• incidence of bradycardia

  15 minutes after intubation

• incidence of reactive hypertension

  15 minutes after intubation

Study Arms (1)

Norepinephrine

EXPERIMENTAL

Drug: norepinephrine bitartrate

Interventions

norepinephrine bitartrate DRUG

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.

Norepinephrine

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Min Yan, Doctor

CONTACT

13757118632; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 5, 2022
• Study Start: December 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)