Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period

General Anesthesia Clinical Trial

Official title:

Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577430
• Other study ID #: 20200915
• Status: Completed
• Phase: N/A
• Start date: September 8, 2019
• Est. completion date: March 16, 2021

Study information

• Verified date: March 2021
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Perioperative stress may increase the incidence of adverse events in the cardiovascular system and lead to poor prognosis. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist, which can inhibit stress response and reduce hemodynamic fluctuations. In different usage plans, dexmedetomidine can have different effects on hemodynamics, myocardial electrical activity, cardiac function. The main purpose was to observe its effects on myocardial electrophysiology and cardiac function during perioperative period. The secondary purpose was to explore the optimal dose of dexmedetomidine that has the least adverse effects on perioperative electrocardia action and cardiac function

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 16, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ages ranged from 18 to 65
• ASA I~II
• patients undergoing elective general anesthesia
• the surgery time for 1~3 h

Exclusion Criteria:

• Preoperative ECG abnormalities, including QTc =440 ms (male), 460ms (female)
• abnormal cardiac conduction, prolonged QT syndrome
• heart disease history, such as pacemaker implantation, unstable angina, congestive heart failure, Heart valve disease
• antiarrhythmic drugs (ß-receptor blockers, calcium channel blockers, tricyclic antidepressants, etc.) that can prolong the QT interval taken within one week before surgery
• coronary heart disease, non-sinus Heart rhythm, bradycardia, tachycardia, other arrhythmia, etc
• intraoperative HR=45 beats/min and need drugs to increase heart rate
• previous allergy to dexmedetomidine
• preoperative electrolyte abnormalities
• emergency surgery, neurological or mental disorders , Liver and kidney dysfunction
• patients who use analgesic pumps after surgery
• refusal of patients

Related Conditions & MeSH terms

• Cardiac Electrophysiology
• Cardiac Function
• Dexmedetomidine
• General Anesthesia

Intervention

Drug:
• Dexmedetomidine
The loading dose with 0.5 µg/kg, maintenance dose with 0.5 µg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts
• Dexmedetomidine
The loading dose with 1 µg/kg, maintenance dose with 0.5 µg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts
• Dexmedetomidine
The loading dose with 1 µg/kg, maintenance dose with 1 µg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts
• Normal saline
Normal saline is used to observe the effect on the electrophysiology of the patients' hearts

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The length of PR,QRS,QTc,QT and Tp-e intervals and the level of iCEB	All the outcomes above should be measured at the time preparing to pump a loading dose,the time after the loading dose finished,at the end of surgery,1h after the surgery finished,24 h after the surgery finished,48 h after the surgery finished,72 h after the surgery finished,1 month after the surgery finished	during surgery to 1 month after the surgery
Secondary	The level of Na+,iCa2+	All the outcomes above should be measured at the time preparing to pump a loading dose,the time after the loading dose finished,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished	perioperative
Secondary	The level of cardiac circulation efficiency	All the outcomes above should be measured at the time preparing to pump a loading dose,the time after the loading dose finished,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished	Perioperative
Secondary	The level of maximum pressure gradient	the time preparing to pump a loading dose,the time after the loading dose finished,the beginning of surgery, 30min after the beginning of surgery,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished	Perioperative
Secondary	The level of heart rate	the time preparing to pump a loading dose,the time after the loading dose finished,the beginning of surgery, 30min after the beginning of surgery,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished	Perioperative
Secondary	The level of mean arterial blood pressure		Perioperative
Secondary	The level of systemic vascular resistance	the time preparing to pump a loading dose,the time after the loading dose finished,the beginning of surgery, 30min after the beginning of surgery,1h after the beginning of the surgery,the end of surgery,1h after the surgery finished	Perioperative
Secondary	The time of eyes opening from surgery ending,the whole surgery,anesthesia		intraoperative
Secondary	The dosage of propofol and remifentanil		intraoperative
Secondary	Total fluid intake from entering the operating room to exiting the PACU		Perioperative