Cholecystolithiasis and Thyroid NoduleNCT03924804
Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
A study testing Ringer's solution acetate in people with Cholecystolithiasis and Thyroid Nodule, run by China Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystolithiasis and Thyroid Nodule
- What is being tested?
- Ringer's solution acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2019to 12 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
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.
Read the 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
- Being tested
- Ringer's solution acetate
- Medical subject headings
- Cholecystolithiasis, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's solution acetateDrug
Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.
Ringer's solution acetateDrug
Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.
Ringer's solution acetateDrug
Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.
| Study group | Role | What they receive |
|---|---|---|
| Group A: 2 ml/kg group | Experimental | Not described Receives: Drug: Ringer's solution acetate |
| Group B: 8 ml/kg group | Experimental | Not described Receives: Drug: Ringer's solution acetate |
| Group C: 16 ml/kg group | Experimental | Not described Receives: Drug: Ringer's solution acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The change of bladder volume
bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound
Measured: baseline and 10 minutes before leaving the post-anesthesia care unite
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start19 Jun 2019
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystolithiasis and Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Doppler Ultrasonography Assessed Bladder and Blood Volume
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924804
- Sponsor's protocol ID
- 20190418
- Status last verified
- May 2022
- First submitted
- 18 Apr 2019
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
- ClinicalTrials.gov ID
- NCT03924804
- Acronym / sponsor ID
- 20190418
- Conditions
- Cholecystolithiasis and Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Doppler Ultrasonography Assessed Bladder and Blood Volume
| Arm | Type | Receives |
|---|---|---|
| Group A: 2 ml/kg group | Experimental | Drug: Ringer's solution acetate |
| Group B: 8 ml/kg group | Experimental | Drug: Ringer's solution acetate |
| Group C: 16 ml/kg group | Experimental | Drug: Ringer's solution acetate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer's solution acetateIntravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction. | Drug | Group A: 2 ml/kg group |
| Ringer's solution acetateIntravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction. | Drug | Group B: 8 ml/kg group |
| Ringer's solution acetateIntravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction. | Drug | Group C: 16 ml/kg group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer's solution acetate in people with Cholecystolithiasis and Thyroid Nodule, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. The change of bladder volume (time frame: baseline and 10 minutes before leaving the post-anesthesia care unite). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.