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

Hypotension on Induction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891951
• Other study ID #: 2023197
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: June 2023
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Jingfeng Bai
• Phone: 15773490489
• Email: bjf159323[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 60-80 years old
• gender unlimited
• ASA: Grade I-?
• 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 ?-? 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

Related Conditions & MeSH terms

• Hypotension
• Hypotension on Induction

Intervention

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.

Locations

Country	Name	City	State
China	China,Chongqing The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Min Su

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	postoperative delirium	Newly diagnosed delirium by the psychiatric department within 30 days after surgery	Within 30 days after surgery
Secondary	postoperative stroke	Any newly diagnosed postoperative neurological dysfunction within 30 days after surgery.	Within 30 days after surgery