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

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: Hemodynamic
• Intervention / Treatment: Behavioral: Guiding rehydration

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

• Study Contact: Name: Qinghe Zhou; Phone Number: 13732573379; Email: jxxmxy@163.com
• Study Contact Backup: Name: Xuelian Wei; Phone Number: 18133822661; Email: 2275076157@qq.com

Study Locations

• China
  • Zhejiang
    • Jiaxing, Zhejiang, China
      • Recruiting
      • Affiliated Hospital of University
      • Contact: Qinghe Zhou; Phone Number: 13732573379; Email: jxxmxy@163.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	The incidence of a 20% drop in blood pressure after propofol induction	1 year

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Jiaxing University
• Investigators: Principal Investigator: Qinghe Zhou, Affiliated Hospital of Jiaxing University

Study record dates

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: propofol; hypotension; hemodynamic; Internal jugular vein; fluid replacement
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• 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