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

NCT04577430 | Completed

• 1 other identifier: 20200915
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

Conditions

Dexmedetomidine; General Anesthesia; Cardiac Electrophysiology; Cardiac Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The level of Na+,iCa2+

  perioperative

• The level of cardiac circulation efficiency

  Perioperative

• The level of maximum pressure gradient

  Perioperative

• The level of heart rate

  Perioperative

• The level of mean arterial blood pressure

  Perioperative

Study Arms (4)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Normal saline

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

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

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

Normal saline DRUG

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

Normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages ranged from 18 to 65
• ASA I\~II
• patients undergoing elective general anesthesia
• the surgery time for 1\~3 h

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, 225012, China

Location

Related Publications (1)

• 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.

  PMID: 36008759 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: October 6, 2020
• Study Start: September 8, 2019
• Primary Completion: February 1, 2021
• Study Completion: March 16, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-03

Locations

CN (1)