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

Yangzhou University

Status: Completed

Conditions: Dexmedetomidine; General Anesthesia; Cardiac Electrophysiology; Cardiac Function

Treatments: Drug: Dexmedetomidine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04577430

20200915

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 (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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 4 patient groups, including a placebo group

Loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Loading dose with 1 μg/kg, maintenance dose with 1 μg/kg

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Normal saline

Placebo Comparator group

Treatment:

Drug: Normal saline