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Completed

NCT Number: NCT05198648

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

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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Key information

Conditions

Myocardial Injury Trigeminal Cardiac Reflex

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trigeminal cardiac reflex

Other

Trigeminal cardiac reflex occurred during the cerebellopontine angle tumor surgery.

Non-trigeminal cardiac reflex

Other

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

Primary outcomes

  1. The incidence of postoperative myocardial injury

    Time frame: Postoperative 1 day.

    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

Secondary outcomes

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

    Time frame: The whole skull base tumor surgery procedure.

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

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2022
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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