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.

Sponsors

Lead sponsor: China Medical University, China

Source China Medical University, China
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.

Overall Status Recruiting
Start Date June 19, 2019
Completion Date September 30, 2020
Primary Completion Date August 30, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
1. The change of bladder volume baseline and 10 minutes before leaving the post-anesthesia care unite
Enrollment 90
Condition
Intervention

Intervention type: Drug

Intervention name: Ringer's solution acetate

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

Arm group label: Group A: 2 ml/kg group

Intervention type: Drug

Intervention name: Ringer's solution acetate

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

Arm group label: Group B: 8 ml/kg group

Intervention type: Drug

Intervention name: Ringer's solution acetate

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

Arm group label: Group C: 16 ml/kg group

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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Contact

Last name: Wen-fei Tan, M.D.,PhD

Phone: 024-83283100

Email: [email protected]

Location
facility status contact the First Hospital of China Medical University Wen-fei Tan, M.D.,Ph.D 024-83283100 [email protected]
Location Countries

China

Verification Date

March 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: China Medical University, China

Investigator full name: Wen-fei Tan

Investigator title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Group A: 2 ml/kg group

Arm group type: Experimental

Arm group label: Group B: 8 ml/kg group

Arm group type: Experimental

Arm group label: Group C: 16 ml/kg group

Arm group type: Experimental

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Doppler Ultrasonography Assessed Bladder and Blood Volume

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov