Trigeminal Nerve Cardiac Reflex During Resection of Cerebellopontine Angle Tumors and Postoperative Myocardial Injury

Myocardial Injury Clinical Trial

Official title:

Trigeminal Nerve Cardiac Reflex During Resection of Cerebellopontine Angle Tumors and Postoperative Myocardial Injury: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198648
• Other study ID #: 2021-12-12
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Beijing Tiantan Hospital
• Contact: Yuming Peng, MD,Ph.D
• Phone: 8610-59976658
• Email: florapym766[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Myocardial injury after noncardiac surgery is significantly related to postoperative 30-day mortality. Trigeminal cardiac reflex is one of the main causes of perioperative cardiac emergency. Therefore, the investigators' aim is to test the hypothesis that trigeminal cardiac reflex associates postoperative myocardial damage in participants undergoing cerebellopontine angle tumor surgery. The investigators will observe the association between trigeminal cardiac reflex and myocardial injury by measuring the concentration of plasma high sensitivity cardiac troponin (hs-cTnT) in participants after cerebellopontine angle tumor surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 591
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing elective cerebellopontine angle tumor surgery.

• Age = 18 years old.

• ASA class I to III.

• All those who sign the informed consent form.

Exclusion Criteria:

• Patients with severe heart disease (including patients with preoperative heart rate < 50 beats / min, severe arrhythmias, such as premature beats, paroxysmal supraventricular tachycardia, atrial flutter or fibrillation, patients with myocardial ischemia < 6 months, heart failure, myocarditis, pericarditis or cardiomyopathy).

• Patients unable to complete preoperative cardiac assessment.

• Patients with chronic kidney disease.

Related Conditions & MeSH terms

• Myocardial Injury
• Neuroma, Acoustic
• Wounds and Injuries

Intervention

Other:
• Trigeminal cardiac reflex
Trigeminal cardiac reflex occurred during the cerebellopontine angle tumor surgery.
• Non-trigeminal cardiac reflex
No trigeminal cardiac reflex occurred during the cerebellopontine angle tumor surgery.

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative myocardial injury	the elevation of plasma high sensitivity cardiac troponin I (hs-cTnI) caused by myocardial ischemia or injury (exclude other causes such as sepsis, pulmonary embolism, atrial fibrillation, etc). The blood samples before and within 24 hours after operation will be collected and measured by Roche's fourth generation hs-cTnI. It is commonly defined as an elevation as any value above the 99th percentile upper reference limit for each specific troponin I assay	Postoperative 1 day.
Secondary	The duration time of trigeminal cardiac reflex during cerebellopontine angle tumor surgery.	The duration time of trigeminal cardiac reflex during cerebellopontine angle tumor surgery.	The whole cerebellopontine angle tumor surgery procedure.