NCT05749328

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 1, 2023

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

December 15, 2022

Last Update Submit

February 18, 2023

Conditions

CarbohydratesAgedPost-induction Hypotension

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypotension

    No surgical manipulation is performed within 20 minutes

    20 minutes after induction of anesthesia

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

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.

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

Interventions

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

Carbohydrate group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Carbohydrates

Study Officials

  • min yan, prof.

    The second affiliated hospital of Zhejiang University hangzhou

    STUDY CHAIR

Central Study Contacts

chaomin wu, doctor

CONTACT

15990027747cmwu@zju.edu.cn

min yan, prof.

CONTACT

zryanmin@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2022

First Posted

March 1, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

March 1, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share