University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
NCT Number: NCT05160207
This prospective observational study aims to determine, if an tracheal intubation-related decrease in heart rate is associated with intraoperative reflex bradycardia in patients undergoing microlaryngoscopy (MLS) in general anesthesia.
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All sexes
Observational
Hamburg, 20246, Germany
Small studies and case series reported precipitous bradycardia or even asystole due to reflex vagal activity during tracheal intubation and/or laryngoscopy attributable to a so called laryngocardiac reflex (reflex bradycardia); however, larger systematic trials are still lacking. For the purpose of MLS, ENT surgeons frequently apply suspension laryngoscopy (Kleinsasser laryngoscope) in order to visualize the glottis and to enable surgery. Severe bradycardia has been reported during MLS that has been suspected to be induced by reflex vagal activity possibly promoted by the superior laryngeal nerve.
It is still unknown, which patients are at risk for relevant intraoperative bradycardia and moreover, which patients might benefit from preemptive measures such as prophylactic application of positive chronotropic drugs like atropine sulfate, epinephrine or glycopyrrolate. Predictive factors for MLS-induced intraoperative bradycardia have not systematically been investigated yet.
In particularly, it is unknown, if patients that present with a preoperative tracheal intubation-related decrease in heart rate have a predisposition for intraoperative reflex bradycardia during MLS.
This prospective observational study aims to determine, if an tracheal intubation-related decrease in heart rate is associated with intraoperative reflex bradycardia in patients undergoing microlaryngoscopy (MLS) in general anesthesia. Moreover, if we find a positive association, we further aim to determine the predictive value of intubation-relatd bradycardia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 hour
Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz)
Time frame: 1 hour
Continuous intraoperative ECG QRS-complex detection (sample rate 1000 hz)
Time frame: 1 hour
Intraoperative application of atropine sulfate by the responsible anesthetist (yes/no)
Time frame: 1 hour
Intraoperative application of other positive inotropic drugs such as epinephrine by responsible anesthetist (yes/no)
Time frame: 1 hour
Continuous intraoperative ECG arrhythmia detection and labeling (sample rate 1000 hz)
Time frame: 1 hour
Intraoperative blood pressure measurement
Time frame: 1 hour
Intraoperative application of catecholamines or vasoactive drugs by responsible anesthetist (yes/no)
Time frame: 1 hour
Intraoperative adverse cardiocirulatory events docuimented by the responsible anethetist
Time frame: 8 hours
Length of stay in the postanesthesia care unit (PACU)
Universitätsklinikum Hamburg-Eppendorf
Other
Tracheal Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia During Microlaryngoscopy -a Prospective Observational Trial
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