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

• Sponsor: Yangzhou University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04934852
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure	Drug: Ephedrine; Drug: Ephedrine; Drug: Ephedrine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Biphasic Effects of Different Doses Ephedrine on Hemodynamics in Elderly Patients Under General Anesthesia
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ephedrine (4mg)	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
Experimental: ephedrine (8mg)	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
Experimental: ephedrine (12mg)	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

Outcome Measures

Primary Outcome Measures

1. The level of systemic vascular resistance [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 Outcome Measures

1. The level of cardiac output [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)

2. The level of cardiac index [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)

3. The level of heart rate [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)

4. The level of heart rate cardiac circulation efficiency [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)

5. The level of maximum pressure gradient [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)

6. The level of mean arterial pressure [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)

7. The amount of infusion volume,propofol and remifentanil [intraoperative]

8. The occurrence of adverse events about the cardiovascular system [from the beginning of the surgery to 30 minutes after being sent to the PACU]

   Yes or No

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu	China

Sponsors and Collaborators

• Yangzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhuan Zhang, Principal Investigator, Yangzhou University
• ClinicalTrials.gov Identifier: NCT04934852
• Other Study ID Numbers: 20210615
• First Posted: Jun 22, 2021
• Last Update Posted: Jul 22, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhuan Zhang, Principal Investigator, Yangzhou University: Ephedrine; Biphasic Effects; Elderly
• Additional relevant MeSH terms: Ephedrine; Pseudoephedrine

Study Results

No Results Posted as of Jul 22, 2021