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Clinical Trials/NCT05160207
NCT05160207
Completed
N/A

Tracheal Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia During Microlaryngoscopy -a Prospective Observational Trial

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country50 target enrollmentNovember 4, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tracheal Intubation
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
50
Locations
1
Primary Endpoint
Intraoperative decrease of the heart rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 4, 2021
End Date
June 13, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients requiring general anesthesia with tracheal intubation for elective MLS

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Intraoperative decrease of the heart rate

Time Frame: 1 hour

Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz)

Secondary Outcomes

  • Adverse cardiocirulatory events(1 hour)
  • PACU stay(8 hours)
  • Application of atropine sulfate(1 hour)
  • Application of positive inotropic drugs(1 hour)
  • Hypotension(1 hour)
  • Cardiac arrhythmias(1 hour)
  • Application of catecholamines or vasoactive drugs(1 hour)
  • Intraoperative asystolia(1 hour)

Study Sites (1)

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