- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03924804
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Thyroid Diseases
- Head and Neck Neoplasms
- Pathological Conditions, Anatomical
- Gallbladder Diseases
- Biliary Tract Diseases
- Calculi
- Thyroid Neoplasms
- Gallstones
- Cholelithiasis
- Cholecystolithiasis
- Thyroid Nodule
- Pharmaceutical Solutions
Other Study ID Numbers
- 20190418
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.
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