Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.

May 12, 2022 updated by: Wen-fei Tan, China Medical University, China
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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: 2 ml/kg group
Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.
Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.
Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.
Experimental: Group B: 8 ml/kg group
Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.
Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.
Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.
Experimental: Group C: 16 ml/kg group
Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.
Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.
Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. The change of bladder volume
Time Frame: baseline and 10 minutes before leaving the post-anesthesia care unite
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Actual)

May 12, 2022

Study Completion (Actual)

May 12, 2022

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 20, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholecystolithiasis and Thyroid Nodule

Clinical Trials on Ringer's solution acetate

Subscribe