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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05749328

Collaborator

(none)

210

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Carbohydrates Aged Post-induction Hypotension	Dietary Supplement: Carbohydrate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
No Intervention: 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

Arm

Intervention/Treatment

Experimental: 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.

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

No Intervention: 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

Outcome Measures

Primary Outcome Measures

Incidence of hypotension [20 minutes after induction of anesthesia]
No surgical manipulation is performed within 20 minutes

Secondary Outcome Measures

Duration of fasting and drinking [1 day before the operation]
Antral cross-sectional area [30 minutes before anesthesia induction]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing elective unilateral joint replacement (total hip or knee)
ASAⅠ-Ⅲ

Exclusion Criteria:

Diagnosed patients at high risk of reflux aspiration (diabetes mellitus, obesity (BMI>30), gastrointestinal obstruction, elevated intracranial pressure, and esophageal disease)
Eating disorders
History of gastrointestinal or epigastric surgery
Recent use of drugs that affect gastrointestinal motility
Heart disease (severe arrhythmias, severe heart valve disease, heart failure, unstable angina on the day of surgery)
Severe poorly controlled hypertension (MAP≥135 mmHg) or hypotension (MAP≤55 mmHg) before induction
Difficult airway
Severe hepatic and renal insufficiency

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: min yan, prof., The second affiliated hospital of Zhejiang University hangzhou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05749328

Other Study ID Numbers:

2022-0949

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Mar 1, 2023