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NCT03497351 Clinical Trial

Effects of Different Kinds of Hypotensive Drugs on Dynamic Hemodynamic Changing in Patients Under Surgeries

General Surgery Clinical Trial

Official title:
Effects of Different Kinds of Antihypertensive Drugs on Dynamic Hemodynamic Changing of During Laparoscopic Gastrectomy and Laparotomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03497351
Other study ID # PLAGHAOC004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date February 15, 2019

Study information
Verified date August 2020
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date February 15, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. ASA ?-?

2. body mass index (BMI) 18-26kg/m2.

3. Hypertension and non-hypertensive patients

4. diabetic no complications

5. no lung, liver, kidney and blood system diseases

6. preoperative examination is basically normal.

Exclusion Criteria:

- Any type of arrhythmia, intraoperative need for other vasoactive drug intervention.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nicardipine
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.
• Urapidil
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.

Locations
Country Name City State
China Chinese PLA General Hospital Beijing Haidian

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary SVV stroke volume variation The period between the begining of anesthesia and the end of operation.
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