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

NCT03497351 | Completed

• 1 other identifier: PLAGHAOC004
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Surgery

Outcome Measures

Primary Outcomes (1)

• SVV

  stroke volume variation

  The period between the begining of anesthesia and the end of operation.

Study Arms (2)

Group N

EXPERIMENTAL

the group treated with nicardipine

Drug: Nicardipine

Group U

EXPERIMENTAL

the group treated with Urapidil

Drug: Urapidil

Interventions

Nicardipine DRUG

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.

Group N

Urapidil DRUG

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.

Group U

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Haidian, 100853, China

Location

MeSH Terms

Interventions

Nicardipine; urapidil

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 13, 2018
• Study Start: April 15, 2018
• Primary Completion: January 31, 2019
• Study Completion: February 15, 2019
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

CN (1)