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

Not Applicable

• Conditions: Blood Pressure
• Interventions: Drug: Ephedrine

• Registration Number: NCT04934852
• Lead Sponsor: Yangzhou University

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Study Start: 2021-07-01
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-22
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ephedrine (12mg)	Ephedrine	-
ephedrine (8mg)	Ephedrine	-
ephedrine (4mg)	Ephedrine	-

Primary Outcome Measures

Name	Time	Method
The level of systemic vascular resistance	during surgery to 30 minutes after being sent to the PACU	The outcomes above should be measured at Immediately after the injection of the drug (T1), 30s after the injection (T2), 1 min after the injection(T3), 1 min30 s after the injection(T4), 2 min after the injection(T5), 2 min30s after the injection(T6), 3 min after the injection(T7), 3 min30s after the injection( T8), 4 min after the injection(T9), 4 min30s after the injection(T10), 5 min after the injection(T11), immediately after surgery (T12), 30 min in PACU (T13)

Secondary Outcome Measures

Name	Time	Method
The level of cardiac index	during surgery to 30 minutes after being sent to the PACU	The outcomes above should be measured at Immediately after the injection of the drug (T1), 30s after the injection (T2), 1 min after the injection(T3), 1 min30 s after the injection(T4), 2 min after the injection(T5), 2 min30s after the injection(T6), 3 min after the injection(T7), 3 min30s after the injection( T8), 4 min after the injection(T9), 4 min30s after the injection(T10), 5 min after the injection(T11), immediately after surgery (T12), 30 min in PACU (T13)
The level of heart rate cardiac circulation efficiency	during surgery to 30 minutes after being sent to the PACU	The outcomes above should be measured at Immediately after the injection of the drug (T1), 30s after the injection (T2), 1 min after the injection(T3), 1 min30 s after the injection(T4), 2 min after the injection(T5), 2 min30s after the injection(T6), 3 min after the injection(T7), 3 min30s after the injection( T8), 4 min after the injection(T9), 4 min30s after the injection(T10), 5 min after the injection(T11), immediately after surgery (T12), 30 min in PACU (T13)
The level of cardiac output	during surgery to 30 minutes after being sent to the PACU	The outcomes above should be measured at Immediately after the injection of the drug (T1), 30s after the injection (T2), 1 min after the injection(T3), 1 min30 s after the injection(T4), 2 min after the injection(T5), 2 min30s after the injection(T6), 3 min after the injection(T7), 3 min30s after the injection( T8), 4 min after the injection(T9), 4 min30s after the injection(T10), 5 min after the injection(T11), immediately after surgery (T12), 30 min in PACU (T13)
The level of maximum pressure gradient	during surgery to 30 minutes after being sent to the PACU	The outcomes above should be measured at Immediately after the injection of the drug (T1), 30s after the injection (T2), 1 min after the injection(T3), 1 min30 s after the injection(T4), 2 min after the injection(T5), 2 min30s after the injection(T6), 3 min after the injection(T7), 3 min30s after the injection( T8), 4 min after the injection(T9), 4 min30s after the injection(T10), 5 min after the injection(T11), immediately after surgery (T12), 30 min in PACU (T13)
The level of heart rate	during surgery to 30 minutes after being sent to the PACU	The outcomes above should be measured at Immediately after the injection of the drug (T1), 30s after the injection (T2), 1 min after the injection(T3), 1 min30 s after the injection(T4), 2 min after the injection(T5), 2 min30s after the injection(T6), 3 min after the injection(T7), 3 min30s after the injection( T8), 4 min after the injection(T9), 4 min30s after the injection(T10), 5 min after the injection(T11), immediately after surgery (T12), 30 min in PACU (T13)
The level of mean arterial pressure	during surgery to 30 minutes after being sent to the PACU	The outcomes above should be measured at Immediately after the injection of the drug (T1), 30s after the injection (T2), 1 min after the injection(T3), 1 min30 s after the injection(T4), 2 min after the injection(T5), 2 min30s after the injection(T6), 3 min after the injection(T7), 3 min30s after the injection( T8), 4 min after the injection(T9), 4 min30s after the injection(T10), 5 min after the injection(T11), immediately after surgery (T12), 30 min in PACU (T13)
The amount of infusion volume,propofol and remifentanil	intraoperative
The occurrence of adverse events about the cardiovascular system	from the beginning of the surgery to 30 minutes after being sent to the PACU	Yes or No

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China