Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia
- Conditions
- Airway ManagementHeart RateTracheal Intubation
- Registration Number
- NCT05160207
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Patients requiring general anesthesia with tracheal intubation for elective MLS
- Age ≥ 18
- Pregnant or breastfeeding women
- Confirmed indications for awake fiberoptic intubation
- Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
- Patients at risk for pulmonary aspiration who qualify for rapid sequence induction
- Cardiac pacemaker
- Atrial fibrillation
- Denial of consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraoperative decrease of the heart rate 1 hour Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz)
- Secondary Outcome Measures
Name Time Method Adverse cardiocirulatory events 1 hour Intraoperative adverse cardiocirulatory events docuimented by the responsible anethetist
PACU stay 8 hours Length of stay in the postanesthesia care unit (PACU)
Application of atropine sulfate 1 hour Intraoperative application of atropine sulfate by the responsible anesthetist (yes/no)
Application of positive inotropic drugs 1 hour Intraoperative application of other positive inotropic drugs such as epinephrine by responsible anesthetist (yes/no)
Hypotension 1 hour Intraoperative blood pressure measurement
Cardiac arrhythmias 1 hour Continuous intraoperative ECG arrhythmia detection and labeling (sample rate 1000 hz)
Application of catecholamines or vasoactive drugs 1 hour Intraoperative application of catecholamines or vasoactive drugs by responsible anesthetist (yes/no)
Intraoperative asystolia 1 hour Continuous intraoperative ECG QRS-complex detection (sample rate 1000 hz)
Trial Locations
- Locations (1)
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany