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

NCT ID: NCT04577430

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-08

Study Completion Date

2021-03-16

Brief Summary

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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

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Conditions

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Dexmedetomidine General Anesthesia Cardiac Electrophysiology Cardiac Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type 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

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yangzhou University

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36008759 (View on PubMed)

Other Identifiers

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20200915

Identifier Type: -

Identifier Source: org_study_id

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