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

NCT ID: NCT05891951

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypotension on Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled clinical study to investigate whether carotid ultrasound-guided fluid therapy reduces the incidence of induced hypotension in elderly patients undergoing gastrointestinal surgery.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
In this study, researchers and subjects were not blind. Anesthesiologists and data collectors were blind. Researchers conducted carotid ultrasound guided fluid therapy for experimental groups according to the groups, anesthesiologists performed routine induction for patients in the two groups, data collectors collected data, and anesthesiologists and data collectors did not know the groups of subjects.

Study Groups

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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.

Group Type EXPERIMENTAL

Fluid therapy under the guide of Carotid ultrasound

Intervention Type OTHER

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.

C-No intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fluid 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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Min Su

OTHER

Sponsor Role lead

Responsible Party

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Min Su

Director,Principal Investigator, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Su Min

Role: STUDY_DIRECTOR

First Affiliated Hospital of Chongqing Medical University

Locations

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China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingfeng Bai

Role: CONTACT

15773490489

Facility Contacts

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jingfeng Bai, master

Role: primary

+8615773490489

Other Identifiers

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2023197

Identifier Type: -

Identifier Source: org_study_id

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