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

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

Study Overview

• Status: Completed
• Conditions: General Anesthesia; Dexmedetomidine; Cardiac Function; Cardiac Electrophysiology
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Dexmedetomidine; Drug: Dexmedetomidine; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225012
      • the Affiliated Hospital of Yangzhou University, Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal saline	Drug: Normal saline; Normal saline is used to observe the effect on the electrophysiology of the patients' hearts
Experimental: Loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg; 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.	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; Drug: 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; Drug: 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
Experimental: Loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg; 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.	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; Drug: 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; Drug: 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
Experimental: Loading dose with 1 μg/kg, maintenance dose with 1 μg/kg; 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.	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; Drug: 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; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
The level of mean arterial blood pressure		Perioperative
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
The time of eyes opening from surgery ending,the whole surgery,anesthesia		intraoperative
The dosage of propofol and remifentanil		intraoperative
Total fluid intake from entering the operating room to exiting the PACU		Perioperative

Collaborators and Investigators

• Sponsor: Yangzhou University

Publications and helpful links

General Publications

• Tan C, Yan S, Shen J, Wu H, Yu L, Wang Y, Tian S, Zhou W, Wu Y, Zhang Z. Effects of dexmedetomidine on cardiac electrophysiology in patients undergoing general anesthesia during perioperative period: a randomized controlled trial. BMC Anesthesiol. 2022 Aug 25;22(1):271. doi: 10.1186/s12871-022-01811-5.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: September 19, 2020
• First Submitted That Met QC Criteria: October 3, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 20200915

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No