Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement

November 13, 2024 updated by: Qing-he Zhou, Affiliated Hospital of Jiaxing University

Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement：A Prospective, Randomized Controlled Study

Compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction, so as to evaluate the feasibility of using the internal jugular vein variability under deep inspiration to guide preoperative fluid infusion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ultrasound records at least one quiet breathing cycle and one deep inhalation cycle to calculate IJVV Propofol was infused target-controlled at 4 μg/ml, and changes in arterial blood pressure within 3 minutes of propofol induction were observed.

Plan to conduct a prospective randomized controlled study to compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction.

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Jiaxing, Zhejiang, China
        • Recruiting
        • Affiliated Hospital of University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age over 60 years； American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ； Surgery with radial artery puncture； Propofol induction；

Exclusion Criteria:

  • BMI≥30kg/m2； People with short necks； Previous hypotension (systolic blood pressure <90mmHg or mean arterial pressure<65mmHg)； Previous poorly controlled hypertension； Cardiac insufficiency , EF value<50%； Upper limb deep vein thrombosis； History of radiotherapy or neck surgery； Inability to maintain a supine position for necessary measurements； Mechanical ventilation status or inability to take deep breaths patients； gastrointestinal surgery； Patients allergic to propofol； Restricted fluid intake；

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guiding rehydration group
According to the 421 fluid replacement principle, preoperative fluid replacement is performed
Behavioral: Guiding rehydration
Preoperative fluid rehydration was performed according to 421 fluid rehydration principles
Active Comparator: Conventional rehydration group
rehydrated within 15 minutes according to 0.2ml/kg/min.
Behavioral: Guiding rehydration
Preoperative fluid rehydration was performed according to 421 fluid rehydration principles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of a 20% drop in blood pressure after propofol induction
Time Frame: 1 year
The incidence of a 20% drop in blood pressure after propofol induction
1 year

Collaborators and Investigators

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

Sponsor

Affiliated Hospital of Jiaxing University

Investigators

  • Principal Investigator: Qinghe Zhou, Affiliated Hospital of Jiaxing 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 (Actual)

August 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 12, 2024

First Submitted That Met QC Criteria

October 12, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KY-520

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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