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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypotension on Induction
• Intervention / Treatment: Other: Fluid therapy under the guide of Carotid ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingfeng Bai; Phone Number: 15773490489; Email: bjf159323@163.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Recruiting
      • China,Chongqing The First Affiliated Hospital of Chongqing Medical University
      • Contact: jingfeng Bai, master; Phone Number: +8615773490489; Email: bjf159323@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of hypotension after anesthesia induction	Hypotension occurred from anesthesia induction to 20 minutes after induction in both groups.	General anesthesia induction from the beginning to 20 minutes after induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 7 days after surgery
postoperative delirium	Newly diagnosed delirium by the psychiatric department within 30 days after surgery	Within 30 days after surgery
postoperative stroke	Any newly diagnosed postoperative neurological dysfunction within 30 days after surgery.	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Min Su
• Investigators: Study Director: Su Min, First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): October 31, 2023

Study Registration Dates

• First Submitted: May 28, 2023
• First Submitted That Met QC Criteria: May 28, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2023197

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No