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

Aged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05749328
• Other study ID #: 2022-0949
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: chaomin wu, doctor
• Phone: 15990027747
• Email: cmwu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

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

2. ASA?-?

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

Related Conditions & MeSH terms

• Aged
• Carbohydrates
• Hypotension
• Post-induction Hypotension

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypotension	No surgical manipulation is performed within 20 minutes	20 minutes after induction of anesthesia
Secondary	Duration of fasting and drinking		1 day before the operation
Secondary	Antral cross-sectional area		30 minutes before anesthesia induction
Secondary	Incidence of hypotension		during the whole operation
Secondary	The dosage of vasoactive drugs		20 minutes after induction of anesthesia
Secondary	Thirst and hunger VAS score		3 hours before and 1 day after the operation
Secondary	Fasting blood glucose and insulin resistance index		3 hours before the operation
Secondary	Incidence of nausea and vomiting		1 day after the operation