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

Not Applicable

Completed

• Conditions: Dexmedetomidine; Cardiac Electrophysiology; General Anesthesia; Cardiac Function
• Interventions: Drug: Normal saline; Drug: Dexmedetomidine

• Registration Number: NCT04577430
• Lead Sponsor: Yangzhou University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-08
• Study First Submitted: 2020-09-19
• Study First Submitted QC: 2020-10-03
• Study First Posted: 2020-10-06
• Primary Completion: 2021-02-01
• Status Verified: 2021-03
• Study Completion: 2021-03-16
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

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

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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 (β-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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	-
Loading dose with 1 μg/kg, maintenance dose with 1 μg/kg	Dexmedetomidine	10 min before induction of anesthesia,the loading dose of dexmedetomidine is 1 μg/kg, and completed in 10 minutes. The maintenance dose is 1 μg/kg per hour during the operation until 0.5 h before the surgery finished.
Loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg	Dexmedetomidine	10 min before induction of anesthesia,the loading dose of dexmedetomidine is 1 μg/kg, and completed in 10 minutes. The maintenance dose is 0.5 μg/kg per hour during the operation until 0.5 h before the surgery finished.
Loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg	Dexmedetomidine	10 min before induction of anesthesia,the loading dose of dexmedetomidine is 0.5 μg/kg, and completed in 10 minutes. The maintenance dose is 0.5 μg/kg per hour during the operation until 0.5 h before the operation finished.

Primary Outcome Measures

Name	Time	Method
The length of PR,QRS,QTc,QT and Tp-e intervals and the level of iCEB	during surgery to 1 month after the surgery	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

Secondary Outcome Measures

Name	Time	Method
The level of systemic vascular resistance	Perioperative	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
The dosage of propofol and remifentanil	intraoperative
The level of cardiac circulation efficiency	Perioperative	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
The level of maximum pressure gradient	Perioperative	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
The level of Na+,iCa2+	perioperative	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
The time of eyes opening from surgery ending,the whole surgery,anesthesia	intraoperative
The level of heart rate	Perioperative	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
The level of mean arterial blood pressure	Perioperative
Total fluid intake from entering the operating room to exiting the PACU	Perioperative

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China