General SurgeryNCT03497351
Effects of Different Kinds of Hypotensive Drugs on Dynamic Hemodynamic Changing in Patients Under Surgeries
A study testing Nicardipine and Urapidil in people with General Surgery, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
SVV is clinically affected by a variety of factors, such as abdominal pressure, body position, tidal volume, type and temperature of liquid treatment, etc. There are few reports on the effects of drugs on SVV. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Surgery
- What is being tested?
- Nicardipine and Urapidil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2018to 15 Feb 2019
- 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
- ASA Ⅰ-Ⅲ
- body mass index (BMI) 18-26kg/m2.
- Hypertension and non-hypertensive patients
- diabetic no complications
- no lung, liver, kidney and blood system diseases
- preoperative examination is basically normal.
Who cannot join
- Any type of arrhythmia, intraoperative need for other vasoactive drug intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Kinds of Antihypertensive Drugs on Dynamic Hemodynamic Changing of During Laparoscopic Gastrectomy and Laparotomy
SVV is clinically affected by a variety of factors, such as abdominal pressure, body position, tidal volume, type and temperature of liquid treatment, etc. There are few reports on the effects of drugs on SVV.
In clinical anesthesia, surgical stimulation and stress can affect patient hemodynamic stability, used in intraoperative vascular active drug is inevitable, they shrink or dilate blood vessels, speed up or slow down the heart rate, makes the ventricular preload and corresponding changes in the SV. Now, there is a study on SVV and PPV in patients with hypertension, but there are few reports on the effect of blood pressure drugs on the changes in patients' threshold.
- Conditions
- General Surgery
- Being tested
- Nicardipine, Urapidil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineDrug
The patients in Group N were infused the 130/0.4 hydroxyethyl starch and sodium chloride injection ( 7 ml/kg, 0.4 ml/kg/min) after anesthesi induction and before skin incision. Then the HR, SAP, DAP, MAP, CO, CI, SV, SVI, PPV and SVV were recorded. When the circulation was stability, Nicardipine was given, and the the 130/0.4 hydroxyethyl starch and sodium chloride injection was infused again.
UrapidilDrug
The patients in Group N were infused the 130/0.4 hydroxyethyl starch and sodium chloride injection ( 7 ml/kg, 0.4 ml/kg/min) after anesthesi induction and before skin incision. Then the HR, SAP, DAP, MAP, CO, CI, SV, SVI, PPV and SVV were recorded. When the circulation was stability, Urapidil was given, and the the 130/0.4 hydroxyethyl starch and sodium chloride injection was infused again.
| Study group | Role | What they receive |
|---|---|---|
| Group N | Experimental | the group treated with nicardipine Receives: Drug: Nicardipine |
| Group U | Experimental | the group treated with Urapidil Receives: Drug: Urapidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVV
stroke volume variation
Measured: The period between the begining of anesthesia and the end of operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start15 Apr 2018
- Primary completion31 Jan 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497351
- Sponsor's protocol ID
- PLAGHAOC004
- Status last verified
- Aug 2020
- First submitted
- 28 Mar 2018
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Kinds of Antihypertensive Drugs on Dynamic Hemodynamic Changing of During Laparoscopic Gastrectomy and Laparotomy
- ClinicalTrials.gov ID
- NCT03497351
- Acronym / sponsor ID
- PLAGHAOC004
- Conditions
- General Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 13 Apr 2018 (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.
SVV is clinically affected by a variety of factors, such as abdominal pressure, body position, tidal volume, type and temperature of liquid treatment, etc. There are few reports on the effects of drugs on SVV.
In clinical anesthesia, surgical stimulation and stress can affect patient hemodynamic stability, used in intraoperative vascular active drug is inevitable, they shrink or dilate blood vessels, speed up or slow down the heart rate, makes the ventricular preload and corresponding changes in the SV. Now, there is a study on SVV and PPV in patients with hypertension, but there are few reports on the effect of blood pressure drugs on the changes in patients' threshold.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group N | Experimental | Drug: Nicardipinethe group treated with nicardipine |
| Group U | Experimental | Drug: Urapidilthe group treated with Urapidil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA Ⅰ-Ⅲ
- body mass index (BMI) 18-26kg/m2.
- Hypertension and non-hypertensive patients
- diabetic no complications
- no lung, liver, kidney and blood system diseases
Key exclusion criteria (1 listed)
- Any type of arrhythmia, intraoperative need for other vasoactive drug intervention.
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 |
|---|---|---|
| NicardipineThe patients in Group N were infused the 130/0.4 hydroxyethyl starch and sodium chloride injection ( 7 ml/kg, 0.4 ml/kg/min) after anesthesi induction and before skin incision. Then the HR, SAP, DAP, MAP, CO, CI, SV, SVI, PPV and SVV were recorded. When the circulation was stability, Nicardipine was given, and the the 130/0.4 hydroxyethyl starch and sodium chloride injection was infused again. | Drug | Group N |
| UrapidilThe patients in Group N were infused the 130/0.4 hydroxyethyl starch and sodium chloride injection ( 7 ml/kg, 0.4 ml/kg/min) after anesthesi induction and before skin incision. Then the HR, SAP, DAP, MAP, CO, CI, SV, SVI, PPV and SVV were recorded. When the circulation was stability, Urapidil was given, and the the 130/0.4 hydroxyethyl starch and sodium chloride injection was infused again. | Drug | Group U |
Primary outcome
SVV
Time frame: The period between the begining of anesthesia and the end of operation.
stroke volume variation
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 26 Aug 2020.
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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 Nicardipine and Urapidil in people with General Surgery, run by Chinese PLA General Hospital 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 6 inclusion and 1 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 26 Aug 2020. 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?
SVV (time frame: The period between the begining of anesthesia and the end of operation.). 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 26 Aug 2020.