Biphasic Effects of Different Doses Ephedrine on Hemodynamics in Elderly Patients Under General Anesthesia
July 15, 2021 updated by: Zhuan Zhang, Yangzhou University
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China
- Recruiting
- The Affiliated Hospital of Yangzhou University, Yangzhou University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ephedrine (4mg)
|
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
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
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
|
|
Experimental: ephedrine (8mg)
|
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
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
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
|
|
Experimental: ephedrine (12mg)
|
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
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
during surgery to 30 minutes after being sent to the PACU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
during surgery to 30 minutes after being sent to the PACU
|
|
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)
|
during surgery to 30 minutes after being sent to the PACU
|
|
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)
|
during surgery to 30 minutes after being sent to the PACU
|
|
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)
|
during surgery to 30 minutes after being sent to the PACU
|
|
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)
|
during surgery to 30 minutes after being sent to the PACU
|
|
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)
|
during surgery to 30 minutes after being sent to the PACU
|
|
The amount of infusion volume,propofol and remifentanil
Time Frame: intraoperative
|
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
|
from the beginning of the surgery to 30 minutes after being sent to the PACU
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
July 30, 2022
Study Registration Dates
First Submitted
June 9, 2021
First Submitted That Met QC Criteria
June 14, 2021
First Posted (Actual)
June 22, 2021
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 15, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Vasoconstrictor Agents
- Nasal Decongestants
- Ephedrine
- Pseudoephedrine
Other Study ID Numbers
- 20210615
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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