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

NCT04934852 | Unknown

• 1 other identifier: 20210615
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Ephedrine; Biphasic Effects; Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The level of cardiac output

  during surgery to 30 minutes after being sent to the PACU

• The level of cardiac index

  during surgery to 30 minutes after being sent to the PACU

• The level of heart rate

  during surgery to 30 minutes after being sent to the PACU

• The level of heart rate cardiac circulation efficiency

  during surgery to 30 minutes after being sent to the PACU

• The level of maximum pressure gradient

  during surgery to 30 minutes after being sent to the PACU

Study Arms (3)

ephedrine (4mg)

EXPERIMENTAL

Drug: Ephedrine

ephedrine (8mg)

EXPERIMENTAL

Drug: Ephedrine

ephedrine (12mg)

EXPERIMENTAL

Drug: Ephedrine

Interventions

Ephedrine 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 (4mg)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

Ephedrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Central Study Contacts

Zhuan Zhang, Professor

CONTACT

+8615062791355; zhangzhuancg@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 22, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: July 22, 2021

Record last verified: 2021-06

Locations

CN (1)