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

Not Applicable

Not yet recruiting

• Conditions: Carbohydrates; Aged; Post-induction Hypotension
• Interventions: Dietary Supplement: Carbohydrate

• Registration Number: NCT05749328
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2023-02-18
• Last Update Submitted: 2023-02-18
• Study Start: 2023-03
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-03
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbohydrate group	Carbohydrate	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.

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	20 minutes after induction of anesthesia	No surgical manipulation is performed within 20 minutes

Secondary Outcome Measures

Name	Time	Method
Antral cross-sectional area	30 minutes before anesthesia induction
Duration of fasting and drinking	1 day before the operation
Incidence of hypotension	during the whole operation
The dosage of vasoactive drugs	20 minutes after induction of anesthesia
Thirst and hunger VAS score	3 hours before and 1 day after the operation
Fasting blood glucose and insulin resistance index	3 hours before the operation
Incidence of nausea and vomiting	1 day after the operation