Back to resultsEffect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
Primary Purpose
Cholecystolithiasis and Thyroid Nodule
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ringer's solution acetate
Ringer's solution acetate
Ringer's solution acetate
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystolithiasis and Thyroid Nodule
Eligibility Criteria
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.
Sites / Locations
- the First Hospital of China Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A: 2 ml/kg group
Group B: 8 ml/kg group
Group C: 16 ml/kg group
Arm Description
Outcomes
Primary Outcome Measures
1. The change of bladder volume
bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT03924804
First Posted
April 18, 2019
Last Updated
May 12, 2022
Sponsor
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT03924804
Brief Title
Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
Official Title
Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
May 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis and Thyroid Nodule
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Doppler Ultrasonography Assessed Bladder and Blood Volume
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: 2 ml/kg group
Arm Type
Experimental
Arm Title
Group B: 8 ml/kg group
Arm Type
Experimental
Arm Title
Group C: 16 ml/kg group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ringer's solution acetate
Intervention Description
Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.
Intervention Type
Drug
Intervention Name(s)
Ringer's solution acetate
Intervention Description
Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.
Intervention Type
Drug
Intervention Name(s)
Ringer's solution acetate
Intervention Description
Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.
Primary Outcome Measure Information:
Title
1. The change of bladder volume
Description
bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound
Time Frame
baseline and 10 minutes before leaving the post-anesthesia care unite
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
the First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
12. IPD Sharing Statement
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Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
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