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

NCT05891951 | Unknown

• 1 other identifier: 2023197
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension on Induction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative acute kidney injury

  Within 7 days after surgery

• postoperative delirium

  Within 30 days after surgery

• postoperative stroke

  Within 30 days after surgery

Study Arms (2)

B-Carotid ultrasound guided fluid therapy

EXPERIMENTAL

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

C-No intervention

NO INTERVENTION

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

Interventions

Fluid therapy under the guide of Carotid ultrasound 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.

B-Carotid ultrasound guided fluid therapy

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Min Su: lead

Study Sites (1)

China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Study Officials

• Su Min

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Jingfeng Bai

CONTACT

15773490489; bjf159323@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director,Principal Investigator, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 7, 2023
• Study Start: May 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

CN (1)