Back to resultsEffect of Preoperative Oral Carbohydrate on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement
Primary Purpose
Carbohydrates, Aged, Post-induction Hypotension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carbohydrate
Sponsored by
About this trial
This is an interventional prevention trial for Carbohydrates
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Carbohydrate group
Contral group
Arm Description
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.
Fasting at 20:00 on the eve of surgery, fasting at 24:00, until the induction of anesthesia on the day of surgery
Outcomes
Primary Outcome Measures
Incidence of hypotension
No surgical manipulation is performed within 20 minutes
Secondary Outcome Measures
Duration of fasting and drinking
Antral cross-sectional area
Incidence of hypotension
The dosage of vasoactive drugs
Thirst and hunger VAS score
Fasting blood glucose and insulin resistance index
Incidence of nausea and vomiting
Full Information
NCT ID
NCT05749328
First Posted
December 15, 2022
Last Updated
February 18, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05749328
Brief Title
Effect of Preoperative Oral Carbohydrate on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement
Official Title
Effect of Preoperative Oral Carbohydrate Shortening the Fasting Period on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbohydrates, Aged, Post-induction Hypotension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carbohydrate group
Arm Type
Experimental
Arm Description
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.
Arm Title
Contral group
Arm Type
No Intervention
Arm Description
Fasting at 20:00 on the eve of surgery, fasting at 24:00, until the induction of anesthesia on the day of surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of hypotension
Description
No surgical manipulation is performed within 20 minutes
Time Frame
20 minutes after induction of anesthesia
Secondary Outcome Measure Information:
Title
Duration of fasting and drinking
Time Frame
1 day before the operation
Title
Antral cross-sectional area
Time Frame
30 minutes before anesthesia induction
Title
Incidence of hypotension
Time Frame
during the whole operation
Title
The dosage of vasoactive drugs
Time Frame
20 minutes after induction of anesthesia
Title
Thirst and hunger VAS score
Time Frame
3 hours before and 1 day after the operation
Title
Fasting blood glucose and insulin resistance index
Time Frame
3 hours before the operation
Title
Incidence of nausea and vomiting
Time Frame
1 day after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chaomin wu, doctor
Phone
15990027747
Email
cmwu@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
min yan, prof.
Email
zryanmin@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
min yan, prof.
Organizational Affiliation
The second affiliated hospital of Zhejiang University hangzhou
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Preoperative Oral Carbohydrate on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement
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