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

NCT05198648 | Completed

• 1 other identifier: 2021-12-12
• Study Type: observational
• Target: 476
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Myocardial Injury; Trigeminal Cardiac Reflex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The duration time of trigeminal cardiac reflex during skull base tumor surgery.

  The whole skull base tumor surgery procedure.

Study Arms (2)

Postoperative myocardial injury

Other: Trigeminal cardiac reflex

Non postoperative myocardial injury

Other: Non-trigeminal cardiac reflex

Interventions

Trigeminal cardiac reflex OTHER

Trigeminal cardiac reflex occurred during the cerebellopontine angle tumor surgery.

Postoperative myocardial injury

Non-trigeminal cardiac reflex OTHER

No trigeminal cardiac reflex occurred during the cerebellopontine angle tumor surgery.

Non postoperative myocardial injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing elective skull base tumor surgery.
• Age ≥ 18 years old.
• ASA class I to III.
• All those who sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Study Officials

• florapym766@163.com Peng, MD,Ph.D

  Beijing Tian Tan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 20, 2022
• Study Start: July 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 9, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)