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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2022

Interventions

  • 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
  • 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
  • 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

Arms, Groups and Cohorts

  • Experimental: ephedrine (4mg)
  • Experimental: ephedrine (8mg)
  • Experimental: ephedrine (12mg)

Clinical Trial Outcome Measures

Primary Measures

  • The level of systemic vascular resistance
    • Time Frame: 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 Measures

  • The level of cardiac output
    • Time Frame: 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 index
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: intraoperative
  • The occurrence of adverse events about the cardiovascular system
    • Time Frame: from the beginning of the surgery to 30 minutes after being sent to the PACU
    • Yes or No

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Yangzhou University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhuan Zhang, Principal Investigator – Yangzhou University
  • Overall Contact(s)
    • Zhuan Zhang, Professor, +8615062791355, zhangzhuancg@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.