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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04934852
Enrollment
70
Registered
2021-06-22
Start date
2021-07-01
Completion date
2022-07-30
Last updated
2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

Ephedrine, Biphasic Effects, Elderly

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.

Interventions

DRUGEphedrine

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

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The level of systemic vascular resistanceduring surgery to 30 minutes after being sent to the PACUThe 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

MeasureTime frameDescription
The level of cardiac indexduring surgery to 30 minutes after being sent to the PACUThe 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 rateduring surgery to 30 minutes after being sent to the PACUThe 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 efficiencyduring surgery to 30 minutes after being sent to the PACUThe 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 outputduring surgery to 30 minutes after being sent to the PACUThe 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 pressureduring surgery to 30 minutes after being sent to the PACUThe 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 remifentanilintraoperative
The occurrence of adverse events about the cardiovascular systemfrom the beginning of the surgery to 30 minutes after being sent to the PACUYes or No
The level of maximum pressure gradientduring surgery to 30 minutes after being sent to the PACUThe 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)

Countries

China

Contacts

Primary ContactZhuan Zhang, Professor
zhangzhuancg@163.com+8615062791355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026