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出境医 / 临床实验 / Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.

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

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.

Condition or disease Intervention/treatment Phase
Cholecystolithiasis and Thyroid Nodule Drug: Ringer's solution acetate Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Doppler Ultrasonography Assessed Bladder and Blood Volume
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : September 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Group A: 2 ml/kg group Drug: Ringer's solution acetate
Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.
Experimental: Group B: 8 ml/kg group Drug: Ringer's solution acetate
Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.
Experimental: Group C: 16 ml/kg group Drug: Ringer's solution acetate
Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.
Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Wen-fei Tan, M.D.,PhD 024-83283100 winfieldtan@hotmail.com

Locations
Layout table for location information
China, Liaoning
the First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact: Wen-fei Tan, M.D.,Ph.D    024-83283100    winfieldtan@hotmail.com   
Sponsors and Collaborators
China Medical University, China
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE June 19, 2019
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
Official Title  ICMJE Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Doppler Ultrasonography Assessed Bladder and Blood Volume
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cholecystolithiasis and Thyroid Nodule
Intervention  ICMJE
  • Drug: Ringer's solution acetate
    Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.
  • Drug: Ringer's solution acetate
    Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.
  • Drug: Ringer's solution acetate
    Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.
Study Arms  ICMJE
  • Experimental: Group A: 2 ml/kg group
    Intervention: Drug: Ringer's solution acetate
  • Experimental: Group B: 8 ml/kg group
    Intervention: Drug: Ringer's solution acetate
  • Experimental: Group C: 16 ml/kg group
    Intervention: Drug: Ringer's solution acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2019) 		90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wen-fei Tan, M.D.,PhD 024-83283100 winfieldtan@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924804
Other Study ID Numbers  ICMJE 20190418
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wen-fei Tan, China Medical University, China
Study Sponsor  ICMJE China Medical University, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account China Medical University, China
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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