How preoperative anxiety affects vasovagal events during spinal anesthesia
The Effect of Preoperative Anxiety Level on Vasovagal Events During Spinal Anesthesia and the Incidence of Vasovagal Events
This project will see if higher anxiety before surgery increases the chance of vasovagal events in adults (18–65, ASA I–II) receiving spinal anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sanliurfa Mehmet Akif Inan Education and Research Hospital Academic / other |
| Locations | 1 site (Sanliurfa) |
| Trial ID | NCT07450014 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study that measures patients' anxiety before surgery using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and then monitors for vasovagal events (bradycardia, hypotension, or syncope) during spinal anesthesia. Adult patients aged 18–65 with ASA physical status I–II who are scheduled for procedures under spinal anesthesia will be enrolled. Researchers will record baseline anxiety scores, intraoperative hemodynamic data, and any vasovagal episodes without altering standard anesthesia care. The study is conducted at a single center, Şanlıurfa Mehmet Akif İnan Training and Research Hospital.
Who should consider this trial
Good fit: Adults aged 18–65, ASA I–II, who are planned for surgery under spinal anesthesia and can give informed consent are the ideal candidates.
Not a fit: Patients who are ASA III–V, pregnant or breastfeeding, those for whom spinal anesthesia is contraindicated, or those not receiving spinal anesthesia are unlikely to benefit from the findings.
Why it matters
Potential benefit: If a link is found, clinicians could identify anxious patients beforehand and take steps to reduce vasovagal risk during spinal anesthesia.
How similar studies have performed: Previous observational reports and smaller studies have suggested a connection between preoperative anxiety and vasovagal or hemodynamic events during neuraxial anesthesia, but prospective data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Soicety of Anesthesiologists (ASA) I-II Patients * 18-65 years patients Exclusion Criteria: * Patients who did not wish to participate in the study voluntarily * patients for whom spinal anesthesia is contraindicated * Pregnant and breastfeeding women * ASA III-IV-V patients
Where this trial is running
Sanliurfa
- Şanlıurfa Mehmet Akif İnan Training and Research Hospital — Sanliurfa, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Veysi YAZAR — Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Study coordinator: Veysi YAZAR
- Email: yazar_2202@hotmail.com
- Phone: +905422216333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.