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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934852
• Other study ID #: 20210615
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: June 2021
• Source: Yangzhou University
• Contact: Zhuan Zhang, Professor
• Phone: +8615062791355
• Email: zhangzhuancg[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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, 4 mg ephedrine in 10 ml saline was usd Intravenously
• 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
• 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

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of systemic vascular resistance	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)	during surgery to 30 minutes after being sent to the PACU
Secondary	The level of cardiac output	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)	during surgery to 30 minutes after being sent to the PACU
Secondary	The level of cardiac index	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)	during surgery to 30 minutes after being sent to the PACU
Secondary	The level of heart rate	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)	during surgery to 30 minutes after being sent to the PACU
Secondary	The level of heart rate cardiac circulation efficiency	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)	during surgery to 30 minutes after being sent to the PACU
Secondary	The level of maximum pressure gradient	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)	during surgery to 30 minutes after being sent to the PACU
Secondary	The level of mean arterial pressure	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)	during surgery to 30 minutes after being sent to the PACU
Secondary	The amount of infusion volume,propofol and remifentanil		intraoperative
Secondary	The occurrence of adverse events about the cardiovascular system	Yes or No	from the beginning of the surgery to 30 minutes after being sent to the PACU