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

NCT ID: NCT03924804

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2022-05-12

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.

Conditions

Cholecystolithiasis and Thyroid Nodule

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A: 2 ml/kg group

Group Type: EXPERIMENTAL

Ringer's solution acetate

Intervention Type: DRUG

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

Group B: 8 ml/kg group

Group Type: EXPERIMENTAL

Ringer's solution acetate

Intervention Type: DRUG

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

Group C: 16 ml/kg group

Group Type: EXPERIMENTAL

Ringer's solution acetate

Intervention Type: DRUG

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

Interventions

Ringer's solution acetate

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

Intervention Type: DRUG

Ringer's solution acetate

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

Intervention Type: DRUG

Ringer's solution acetate

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Wen-fei Tan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

20190418

Identifier Type: -

Identifier Source: org_study_id