Clinical trial NCT05160207: Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia
Official title: Tracheal Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia During Microlaryngoscopy -a Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheal Intubation
Airway Management
Heart Rate
Keywords: Laryngoscopy
Bradycardia
Microlaryngoscopy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients requiring general anesthesia with tracheal intubation for elective MLS in a tertiary care hospital who consent to participate within the study period.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative decrease of the heart rate
timeFrame: 1 hour
Secondary outcomes:
measure: Intraoperative asystolia
timeFrame: 1 hour
measure: Application of atropine sulfate
timeFrame: 1 hour
measure: Application of positive inotropic drugs
timeFrame: 1 hour
measure: Cardiac arrhythmias
timeFrame: 1 hour
measure: Hypotension
timeFrame: 1 hour
measure: Application of catecholamines or vasoactive drugs
timeFrame: 1 hour
measure: Adverse cardiocirulatory events
timeFrame: 1 hour
measure: PACU stay
timeFrame: 8 hours
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Martin Petzoldt, MD
role: STUDY_CHAIR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Tanja Peters
role: STUDY_CHAIR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Christian Zöllner, MD
role: STUDY_CHAIR
References: