Biphasic Effects of Different Doses Ephedrine on Hemodynamics in Elderly Patients Under General Anesthesia

NCT ID: NCT04934852

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-30

Brief Summary

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Ephedrine is commonly clinically vasoactive drugs, which can constrict blood vessels and increase blood pressure. Ephedrine can not only stimulate α receptors, but also β receptors, that's to say, it can increase heart rate, stroke volume, and cardiac output, but it also can decrease the level of systemic vascular resistance. This research aims to observe the short-term vasodilator effect of diffierent doses of ephedrine used in elderly patients under general anesthesia in clinical practice, and analyze the main reasons for this phenomenon and take preventive actions to minimize the possibility of further lowering of blood pressure to provide references for clinical rational use of drugs.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ephedrine (4mg)

Group Type EXPERIMENTAL

Ephedrine

Intervention Type DRUG

When elderly patients had hypotension (invasive blood pressure drops \>20% from the baseline value or \<100 mmHg, or MAP \<70mmHg) 20 minutes after anesthesia induction, 4 mg ephedrine in 10 ml saline was usd Intravenously

ephedrine (8mg)

Group Type EXPERIMENTAL

Ephedrine

Intervention Type DRUG

When elderly patients had hypotension (invasive blood pressure drops \>20% from the baseline value or \<100 mmHg, or MAP \<70mmHg) 20 minutes after anesthesia induction, 8 mg ephedrine in 10 ml saline was usd Intravenously

ephedrine (12mg)

Group Type EXPERIMENTAL

Ephedrine

Intervention Type DRUG

When elderly patients had hypotension (invasive blood pressure drops \>20% from the baseline value or \<100 mmHg, or MAP \<70mmHg) 20 minutes after anesthesia induction, 12 mg ephedrine in 10 ml saline was usd Intravenously

Interventions

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Ephedrine

When elderly patients had hypotension (invasive blood pressure drops \>20% from the baseline value or \<100 mmHg, or MAP \<70mmHg) 20 minutes after anesthesia induction, 4 mg ephedrine in 10 ml saline was usd Intravenously

Intervention Type DRUG

Ephedrine

When elderly patients had hypotension (invasive blood pressure drops \>20% from the baseline value or \<100 mmHg, or MAP \<70mmHg) 20 minutes after anesthesia induction, 8 mg ephedrine in 10 ml saline was usd Intravenously

Intervention Type DRUG

Ephedrine

When elderly patients had hypotension (invasive blood pressure drops \>20% from the baseline value or \<100 mmHg, or MAP \<70mmHg) 20 minutes after anesthesia induction, 12 mg ephedrine in 10 ml saline was usd Intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages ranged from 65 to 80
* ASA I\~II
* patients undergoing elective general anesthesia
* BMI 18.5-30.0

Exclusion Criteria

* refusal of patients
* emergency surgery, neurological or mental disorders , Liver and kidney dysfunction
* previous allergy to ephedrine and phenylephrine
* heart disease history, such as pacemaker implantation, unstable angina, congestive heart failure, Heart valve disease
* nerve, digestive, endocrine system diseases, and affect intravascular Fluid volume or balance diseases (such as inflammatory diseases or gastrointestinal obstructive diseases)
* emergency surgery
* malignant tumors
* tachycardia (HR\>100)
* bradycardia ( HR\<50)
* intraoperative hypotension that is difficult to correct with ephedrine and phenylephrine
* use of other vasoactive drugs.
* surgery time \<40 min
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yangzhou University

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhuan Zhang, Professor

Role: CONTACT

+8615062791355

Facility Contacts

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Zhuan Zhang, professor

Role: primary

+8615062791355 ext. +8615062791355

Other Identifiers

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20210615

Identifier Type: -

Identifier Source: org_study_id

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