Clinical trial NCT04577430: Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period
Official title: Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexmedetomidine
General Anesthesia
Cardiac Electrophysiology
Cardiac Function
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: The length of PR,QRS,QTc,QT and Tp-e intervals and the level of iCEB
timeFrame: during surgery to 1 month after the surgery
Secondary outcomes:
measure: The level of Na+,iCa2+
timeFrame: perioperative
measure: The level of cardiac circulation efficiency
timeFrame: Perioperative
measure: The level of maximum pressure gradient
timeFrame: Perioperative
measure: The level of heart rate
timeFrame: Perioperative
measure: The level of mean arterial blood pressure
timeFrame: Perioperative
measure: The level of systemic vascular resistance
timeFrame: Perioperative
measure: The time of eyes opening from surgery ending,the whole surgery,anesthesia
timeFrame: intraoperative
measure: The dosage of propofol and remifentanil
timeFrame: intraoperative
measure: Total fluid intake from entering the operating room to exiting the PACU
timeFrame: Perioperative
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References:
citation: 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.