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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05160207
Other study ID # 2021-10378-BO-ff
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2021
Est. completion date June 13, 2022

Study information

Verified date July 2023
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 50
Est. completion date June 13, 2022
Est. primary completion date June 13, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Germany University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative decrease of the heart rate Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz) 1 hour
Secondary Intraoperative asystolia Continuous intraoperative ECG QRS-complex detection (sample rate 1000 hz) 1 hour
Secondary Application of atropine sulfate Intraoperative application of atropine sulfate by the responsible anesthetist (yes/no) 1 hour
Secondary Application of positive inotropic drugs Intraoperative application of other positive inotropic drugs such as epinephrine by responsible anesthetist (yes/no) 1 hour
Secondary Cardiac arrhythmias Continuous intraoperative ECG arrhythmia detection and labeling (sample rate 1000 hz) 1 hour
Secondary Hypotension Intraoperative blood pressure measurement 1 hour
Secondary Application of catecholamines or vasoactive drugs Intraoperative application of catecholamines or vasoactive drugs by responsible anesthetist (yes/no) 1 hour
Secondary Adverse cardiocirulatory events Intraoperative adverse cardiocirulatory events docuimented by the responsible anethetist 1 hour
Secondary PACU stay Length of stay in the postanesthesia care unit (PACU) 8 hours
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