NCT06641505

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 15, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

October 12, 2024

Last Update Submit

November 13, 2024

Conditions

Keywords

Internal jugular veinpropofolhemodynamichypotensionfluid replacement

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Guiding rehydration group

EXPERIMENTAL

According to the 421 fluid replacement principle, preoperative fluid replacement is performed

Behavioral: Guiding rehydration

Conventional rehydration group

ACTIVE COMPARATOR

rehydrated within 15 minutes according to 0.2ml/kg/min.

Behavioral: Guiding rehydration

Interventions

Preoperative fluid rehydration was performed according to 421 fluid rehydration principles

Conventional rehydration groupGuiding rehydration group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of University

Jiaxing, Zhejiang, China

RECRUITING

Related Publications (1)

  • Wei XL, Xi YZ, Xie L, Li ZP, Tang HL, Zhou QH. Effects of liquid resuscitation guided by internal jugular vein variability during deep inhalation on preventing propofol-induced hypotension in elderly patients. BMC Anesthesiol. 2025 Jul 17;25(1):350. doi: 10.1186/s12871-025-03227-3.

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Qinghe Zhou

    Affiliated Hospital of Jiaxing University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinghe Zhou

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
single
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 12, 2024

First Posted

October 15, 2024

Study Start

August 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

November 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations