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Completed

NCT Number: NCT04577430

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

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Key information

Conditions

Dexmedetomidine Cardiac Electrophysiology Cardiac Function General Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, 225012, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

normal saline

Drug

Normal saline is used to observe the effect on the electrophysiology of the patients' hearts

Primary outcomes

  1. The length of PR,QRS,QTc,QT and Tp-e intervals and the level of iCEB

    Time frame: 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 outcomes

  1. The level of Na+,iCa2+

    Time frame: 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

  2. The level of cardiac circulation efficiency

    Time frame: 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

  3. The level of maximum pressure gradient

    Time frame: 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

  4. The level of heart rate

    Time frame: 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

  5. The level of mean arterial blood pressure

    Time frame: Perioperative

  6. The level of systemic vascular resistance

    Time frame: 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

  7. The time of eyes opening from surgery ending,the whole surgery,anesthesia

    Time frame: intraoperative

  8. The dosage of propofol and remifentanil

    Time frame: intraoperative

  9. Total fluid intake from entering the operating room to exiting the PACU

    Time frame: Perioperative

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2020
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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