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CompletedNCT05198648Updated Feb 14, 2025

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

An observational study in Myocardial Injury and Trigeminal Cardiac Reflex, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Beijing Tiantan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
476
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Myocardial Injury
  • Trigeminal Cardiac Reflex
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In context

Neuroma, Acoustic

98 studies on the registry are indexed under Neuroma, Acoustic; 27 are open to participants now.

This study's enrollment of 476 is above the median of 80 across 24 observational studies indexed under Neuroma, Acoustic.

Browse Neuroma, Acoustic studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
476 participants (actual)
Patient registry
No

Groups and cohorts

  • Postoperative myocardial injury

    Other: Trigeminal cardiac reflex

  • Non postoperative myocardial injury

    Other: Non-trigeminal cardiac reflex

Interventions

  • OtherTrigeminal cardiac reflex

    Trigeminal cardiac reflex occurred during the cerebellopontine angle tumor surgery.

  • OtherNon-trigeminal cardiac reflex

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

06

What researchers measure

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

    Time frame: Postoperative 1 day.

Secondary outcomes

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

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

    Time frame: The whole skull base tumor surgery procedure.

07

Study locations

1 site
  • Beijing Tian Tan Hospital, Capital Medical University
    Beijing, Beijing 100070, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05198648
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Yuming Peng (Deputy chief of Department of Anesthesiology, Beijing Tiantan Hospital) — Principal investigator
First posted
Jan 20, 2022
Start date
Jul 1, 2022
Primary completion
Oct 1, 2024
Completion
Oct 9, 2024
Last update
Feb 14, 2025

Study contacts

florapym766@163.com Peng, MD,Ph.D
principal investigator · Beijing Tian Tan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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