Effect of Preoperative Oral Carbohydrate on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement

NCT ID: NCT05749328

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2024-06-30

Brief Summary

The goal of this Randomized controlled trial is to investigate the effect of shortening the duration of preoperative oral carbohydrate drinks on blood pressure after anesthesia induction in elderly patients undergoing joint replacement surgery. The main question it aims to answer is Whether preoperative oral carbohydrate drinks can reduce the incidence of hypotension after anesthesia-induced hypotension in elderly patients undergoing joint replacement surgery.According to the numerical table method, the patients in the experimental group will drink carbohydrate drinks the night before the operation and 3 hours before the operation, and the control group patients will routinely fast

Conditions

Carbohydrates; Aged; Post-induction Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Carbohydrate group

Fasting at 20:00 on the eve of surgery, give 800ml of carbohydrate drink, the patient drinks freely, no more than 200ml per hour, to 3h before surgery, give carbohydrate drink again, according to 5ml/kg calculated dose, maximum 400ml, drink within 30 minutes.

Group Type: EXPERIMENTAL

Carbohydrate

Intervention Type: DIETARY_SUPPLEMENT

To ensure the safety of the trial, preoperative gastric ultrasound measurements will be performed on all patients to assess their gastric volume. See above for other details

Contral group

Fasting at 20:00 on the eve of surgery, fasting at 24:00, until the induction of anesthesia on the day of surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Carbohydrate

To ensure the safety of the trial, preoperative gastric ultrasound measurements will be performed on all patients to assess their gastric volume. See above for other details

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Patients undergoing elective unilateral joint replacement (total hip or knee)

2. ASAⅠ-Ⅲ

Exclusion Criteria

1. Diagnosed patients at high risk of reflux aspiration (diabetes mellitus, obesity (BMI>30), gastrointestinal obstruction, elevated intracranial pressure, and esophageal disease)

2. Eating disorders

3. History of gastrointestinal or epigastric surgery

4. Recent use of drugs that affect gastrointestinal motility

5. Heart disease (severe arrhythmias, severe heart valve disease, heart failure, unstable angina on the day of surgery)

6. Severe poorly controlled hypertension (MAP≥135 mmHg) or hypotension (MAP≤55 mmHg) before induction

7. Difficult airway

8. Severe hepatic and renal insufficiency

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

min yan, prof.

Role: STUDY_CHAIR

The second affiliated hospital of Zhejiang University hangzhou

Central Contacts

chaomin wu, doctor

Role: CONTACT

cmwu@zju.edu.cn

15990027747

min yan, prof.

Role: CONTACT

zryanmin@zju.edu.cn

Other Identifiers

2022-0949

Identifier Type: -

Identifier Source: org_study_id