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RecruitingNCT05891951Updated Jun 13, 2023

Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery

An interventional study of Fluid therapy under the guide of Carotid ultrasound in Hypotension on Induction, sponsored by Min Su. Recruiting at 1 site in China. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-13.

Sponsored by Min Su · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Oct 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn about Whether carotid ultrasound guided fluid management can reduce the incidence of hypotension after general anesthesia induction in elderly patients undergoing gastrointestinal surgery.

The main question[s] it aims to answer are:

Whether fluid therapy reduces the incidence of general anaesthesia induced hypotension in elderly patients undergoing gastrointestinal surgery.

Whether carotid ultrasound can guide fluid management in elderly patients undergoing gastrointestinal surgery.

Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced. There is a comparison group: No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced.

02

Conditions studied

  • Hypotension on Induction

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Min Su is the lead sponsor of 12 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 60-80 years old
  • gender unlimited
  • ASA: Grade I-Ⅲ
  • BMI:18-30kg/㎡
  • Patients undergoing elective gastrointestinal surgery under general anesthesia Informed consent

Exclusion criteria

Exclusion Criteria:

  • Carotid artery stenosis ≥50%
  • Patients with heart valve disease
  • Patients with left ventricular ejection fraction \< 50%
  • Patients with cardiac dysfunction (NYHA grade Ⅲ-Ⅳ and/or NTproBNP≥900pg/ml)
  • Patients Combined with renal insufficiency (creatinine ≥178μmol/L, and/or blood urea nitrogen > 9mmol/L)
  • Preoperative systolic blood pressure> 160mmHg or diastolic blood pressure > 100mmHg
  • Refuse to participate in the test
  • Patients participating in other clinical trials
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    B-Carotid ultrasound guided fluid therapy

    Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced.

    Other: Fluid therapy under the guide of Carotid ultrasound

  • No intervention
    C-No intervention

    No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced.

Interventions

  • OtherFluid therapy under the guide of Carotid ultrasound

    Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient. If volume is sufficient, no fluid therapy will be given.

06

What researchers measure

Primary outcomes

  1. Occurrence of hypotension after anesthesia induction

    Hypotension occurred from anesthesia induction to 20 minutes after induction in both groups.

    Time frame: General anesthesia induction from the beginning to 20 minutes after induction

Secondary outcomes

  1. Postoperative acute kidney injury

    Postoperative creatinine increased for a short period of time to more than 0.3mg/dl (26.5μmol/L) or to more than 1.5 times the preoperative creatinine concentration.

    Time frame: Within 7 days after surgery

  2. postoperative delirium

    Newly diagnosed delirium by the psychiatric department within 30 days after surgery

    Time frame: Within 30 days after surgery

  3. postoperative stroke

    Any newly diagnosed postoperative neurological dysfunction within 30 days after surgery.

    Time frame: Within 30 days after surgery

07

Study locations

1 of 1 sites recruiting
  • China,Chongqing The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing 400016, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05891951
Lead sponsor
Min Su
Responsible party
Min Su (Director,Principal Investigator, Clinical Professor, First Affiliated Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Jun 7, 2023
Start date
May 1, 2023
Primary completion
Oct 31, 2023 (estimated)
Completion
Oct 31, 2023 (estimated)
Last update
Jun 13, 2023

Study contacts

Jingfeng Bai
Contact
bjf159323@163.com
15773490489
Su Min
study director · First Affiliated Hospital of Chongqing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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