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

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

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 skull base 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 skull base tumor surgery.

Study Overview

• Status: Completed
• Conditions: Myocardial Injury; Trigeminal Cardiac Reflex
• Intervention / Treatment: Other: Trigeminal cardiac reflex; Other: Non-trigeminal cardiac reflex

• Study Type: Observational
• Enrollment (Actual): 476

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tian Tan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged more than 18 years old with American Society of Anesthesiology status I to III who will be scheduled to receive elective skull base tumor surgery under general anesthesia. Patients with trigeminal cardiac reflex during surgery will be included in the exposure group while patients without trigeminal cardiac reflex during surgery will be included in the non-exposure group.

Description

Inclusion Criteria:

• Patients undergoing elective skull base 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Postoperative myocardial injury	Other: Trigeminal cardiac reflex; Trigeminal cardiac reflex occurred during the cerebellopontine angle tumor surgery.
Non postoperative myocardial injury	Other: Non-trigeminal cardiac reflex; No trigeminal cardiac reflex occurred during the cerebellopontine angle tumor surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration time of trigeminal cardiac reflex during skull base tumor surgery.	The duration time of trigeminal cardiac reflex during skull base tumor surgery.	The whole skull base tumor surgery procedure.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: florapym766@163.com Peng, MD,Ph.D, Beijing Tian tan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 9, 2024

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Neuroendocrine Tumors; Ear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Neuroma; Cranial Nerve Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neurilemmoma; Wounds and Injuries; Neuroma, Acoustic
• Other Study ID Numbers: 2021-12-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No