CarbohydratesNCT05749328
Effect of Preoperative Oral Carbohydrate on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement
A study testing Carbohydrate in people with Carbohydrates and Aged, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Carbohydrates, Aged, Post-induction Hypotension
- What is being tested?
- Carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients undergoing elective unilateral joint replacement (total hip or knee)
- ASAⅠ-Ⅲ
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
min yan, prof. contact
About this study
Official title: Effect of Preoperative Oral Carbohydrate Shortening the Fasting Period on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement
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
- Being tested
- Carbohydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbohydrateDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate group | Experimental | 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. Receives: Dietary Supplement: Carbohydrate |
| Contral group | No intervention | Fasting at 20:00 on the eve of surgery, fasting at 24:00, until the induction of anesthesia on the day of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
No surgical manipulation is performed within 20 minutes
Measured: 20 minutes after induction of anesthesia
Secondary outcomes (7)
Duration of fasting and drinking
Measured: 1 day before the operation
Antral cross-sectional area
Measured: 30 minutes before anesthesia induction
Incidence of hypotension
Measured: during the whole operation
The dosage of vasoactive drugs
Measured: 20 minutes after induction of anesthesia
Thirst and hunger VAS score
Measured: 3 hours before and 1 day after the operation
Fasting blood glucose and insulin resistance index
Measured: 3 hours before the operation
Incidence of nausea and vomiting
Measured: 1 day after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarbohydratesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- min yan, prof., Study chair, The second affiliated hospital of Zhejiang University hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749328
- Sponsor's protocol ID
- 2022-0949
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Carbohydrate Shortening the Fasting Period on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement
- ClinicalTrials.gov ID
- NCT05749328
- Acronym / sponsor ID
- 2022-0949
- Conditions
- Carbohydrates, Aged, Post-induction Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate group | Experimental | Dietary Supplement: CarbohydrateFasting 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. |
| Contral group | No intervention | –Fasting at 20:00 on the eve of surgery, fasting at 24:00, until the induction of anesthesia on the day of surgery |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective unilateral joint replacement (total hip or knee)
- ASAⅠ-Ⅲ
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbohydrateTo 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 | Dietary supplement | Carbohydrate group |
Primary outcome
Incidence of hypotension
Time frame: 20 minutes after induction of anesthesia
No surgical manipulation is performed within 20 minutes
7 secondary outcomes
Duration of fasting and drinking
Time frame: 1 day before the operation
Antral cross-sectional area
Time frame: 30 minutes before anesthesia induction
Incidence of hypotension
Time frame: during the whole operation
The dosage of vasoactive drugs
Time frame: 20 minutes after induction of anesthesia
Thirst and hunger VAS score
Time frame: 3 hours before and 1 day after the operation
Fasting blood glucose and insulin resistance index
Time frame: 3 hours before the operation
Incidence of nausea and vomiting
Time frame: 1 day after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
min yan, prof. contact
min yan, prof. study chair
The second affiliated hospital of Zhejiang University hangzhou
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate in people with Carbohydrates and Aged, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chaomin wu, doctor (15990027747, cmwu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension (time frame: 20 minutes after induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.