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Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05160207
Enrollment
50
Registered
2021-12-16
Start date
2021-11-04
Completion date
2022-06-13
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management, Heart Rate, Tracheal Intubation

Keywords

Laryngoscopy, Bradycardia, Microlaryngoscopy

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.

Interventions

None listed

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients requiring general anesthesia with tracheal intubation for elective MLS * Age ≥ 18

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative decrease of the heart rate1 hourContinuous intraoperative ECG heart rate measurement (sample rate 1000 hz)

Secondary

MeasureTime frameDescription
Application of atropine sulfate1 hourIntraoperative application of atropine sulfate by the responsible anesthetist (yes/no)
Application of positive inotropic drugs1 hourIntraoperative application of other positive inotropic drugs such as epinephrine by responsible anesthetist (yes/no)
Cardiac arrhythmias1 hourContinuous intraoperative ECG arrhythmia detection and labeling (sample rate 1000 hz)
Intraoperative asystolia1 hourContinuous intraoperative ECG QRS-complex detection (sample rate 1000 hz)
Application of catecholamines or vasoactive drugs1 hourIntraoperative application of catecholamines or vasoactive drugs by responsible anesthetist (yes/no)
Adverse cardiocirulatory events1 hourIntraoperative adverse cardiocirulatory events docuimented by the responsible anethetist
PACU stay8 hoursLength of stay in the postanesthesia care unit (PACU)
Hypotension1 hourIntraoperative blood pressure measurement

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026