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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03924804
Other study ID # 20190418
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 19, 2019
Est. completion date May 12, 2022

Study information

Verified date May 2022
Source China Medical University, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the trial was to explore the effect of different infusion volume on perioperative bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound and transthoracic echocardiography.


Description:

The objective of the trial was to evaluate the effects of different infusion volume of Ringer's solution acetate (2 ml/kg,8ml/kg, 16ml/kg) on bladder volume, hemodynamics,transthoracic echocardiography and vascular ultrasound including the inferior vena cava(IVC) and the right subclavian vein(SCV) diameter and the IVC and SCV collapsibility index in patients undergoing daytime surgery through a randomized controlled clinical study, so as to provide better guidance for clinical transfusion avoiding bladder catheterization . The patients in this trial were visited before induction and discharge from the postanaesthesia .We also collected the first time and times of micturition and whether the patients have the dysuria.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 12, 2022
Est. primary completion date May 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 1. ethnic Chinese; - 2. age, 18 to 65 years old; - 3. American Society of Anaesthesiologists (ASA) physical status I or II; - 4. Daytime patients scheduled for general anesthesia Exclusion Criteria: - Patients unwilling to cooperate with the experiment - Body mass index exceeding 30 kg/m2; - Patients with a history of heart ,liver and Renal failure ,hypertension,diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study. - Patients with the urinary diseases, such as kidney, ureteral calculi and tumors, prostatic hypertrophy.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ringer's solution acetate
Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.
Ringer's solution acetate
Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.
Ringer's solution acetate
Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.

Locations

Country Name City State
China the First Hospital of China Medical University Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1. The change of bladder volume bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound baseline and 10 minutes before leaving the post-anesthesia care unite