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Completed

NCT Number: NCT05160207

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intraoperative decrease of the heart rate

    Time frame: 1 hour

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

Secondary outcomes

  1. Intraoperative asystolia

    Time frame: 1 hour

    Continuous intraoperative ECG QRS-complex detection (sample rate 1000 hz)

  2. Application of atropine sulfate

    Time frame: 1 hour

    Intraoperative application of atropine sulfate by the responsible anesthetist (yes/no)

  3. Application of positive inotropic drugs

    Time frame: 1 hour

    Intraoperative application of other positive inotropic drugs such as epinephrine by responsible anesthetist (yes/no)

  4. Cardiac arrhythmias

    Time frame: 1 hour

    Continuous intraoperative ECG arrhythmia detection and labeling (sample rate 1000 hz)

  5. Hypotension

    Time frame: 1 hour

    Intraoperative blood pressure measurement

  6. Application of catecholamines or vasoactive drugs

    Time frame: 1 hour

    Intraoperative application of catecholamines or vasoactive drugs by responsible anesthetist (yes/no)

  7. Adverse cardiocirulatory events

    Time frame: 1 hour

    Intraoperative adverse cardiocirulatory events docuimented by the responsible anethetist

  8. PACU stay

    Time frame: 8 hours

    Length of stay in the postanesthesia care unit (PACU)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2021
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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