Clinical trial NCT04934852: Biphasic Effects of Different Doses Ephedrine on Hemodynamics in Elderly Patients Under General Anesthesia
Official title: Biphasic Effects of Different Doses Ephedrine on Hemodynamics in Elderly Patients Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Keywords: Ephedrine
Biphasic Effects
Elderly
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: The level of systemic vascular resistance
timeFrame: during surgery to 30 minutes after being sent to the PACU
Secondary outcomes:
measure: The level of cardiac output
timeFrame: during surgery to 30 minutes after being sent to the PACU
measure: The level of cardiac index
timeFrame: during surgery to 30 minutes after being sent to the PACU
measure: The level of heart rate
timeFrame: during surgery to 30 minutes after being sent to the PACU
measure: The level of heart rate cardiac circulation efficiency
timeFrame: during surgery to 30 minutes after being sent to the PACU
measure: The level of maximum pressure gradient
timeFrame: during surgery to 30 minutes after being sent to the PACU
measure: The level of mean arterial pressure
timeFrame: during surgery to 30 minutes after being sent to the PACU
measure: The amount of infusion volume,propofol and remifentanil
timeFrame: intraoperative
measure: The occurrence of adverse events about the cardiovascular system
timeFrame: from the beginning of the surgery to 30 minutes after being sent to the PACU
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References: