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

Primary Purpose

Hypotension on Induction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fluid therapy under the guide of Carotid ultrasound
Sponsored by
Min Su
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension on Induction

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • China,Chongqing The First Affiliated Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

B-Carotid ultrasound guided fluid therapy

C-No intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
postoperative delirium
Newly diagnosed delirium by the psychiatric department within 30 days after surgery
postoperative stroke
Any newly diagnosed postoperative neurological dysfunction within 30 days after surgery.

Full Information

First Posted
May 28, 2023
Last Updated
June 11, 2023
Sponsor
Min Su
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1. Study Identification

Unique Protocol Identification Number
NCT05891951
Brief Title
Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery
Official Title
Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min Su

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension on Induction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B-Carotid ultrasound guided fluid therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
C-No intervention
Arm Type
No Intervention
Arm Description
No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced.
Intervention Type
Other
Intervention Name(s)
Fluid therapy under the guide of Carotid ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of hypotension after anesthesia induction
Description
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 Outcome Measure Information:
Title
Postoperative acute kidney injury
Description
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
Title
postoperative delirium
Description
Newly diagnosed delirium by the psychiatric department within 30 days after surgery
Time Frame
Within 30 days after surgery
Title
postoperative stroke
Description
Any newly diagnosed postoperative neurological dysfunction within 30 days after surgery.
Time Frame
Within 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingfeng Bai
Phone
15773490489
Email
bjf159323@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Min
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jingfeng Bai, master
Phone
+8615773490489
Email
bjf159323@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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