The Effect of Preoperative Anxiety Level on Vasovagal Events During Spinal Anesthesia and the Incidence of Vasovagal Events

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07450014

Enrollment

1500

Registered

2026-03-04

Start date

2026-04-15

Completion date

2026-09-15

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Spinal Anesthesia

Keywords

Amsterdam Preoperative Anxiety and Information Scale, sencop

Brief summary

To determine the anxiety levels of patients undergoing spinal anesthesia before surgery and to observe the effect of this anxiety level on vasovagal events that may be observed during spinal anesthesia.

Detailed description

Spinal anesthesia is a frequently used anesthesia method in clinics because it creates a rapid and effective sensory and motor block by injecting a low dose of local anesthetic into the subarachnoid space. Its success rate is over 90%. Vasovagal syncope (neurocardiogenic syncope; sudden loss of consciousness due to decreased blood flow to the brain and arterial blood pressure through neural mechanisms as a result of vasodilation. In this condition, cardiac arrest may occur following the development of bradycardia and hypotension. It is assumed that syncope may be related to anxiety, emotional triggers, or pain, and that this triggers the parasympathetic pathway leading to hypotension and bradycardia. Psychogenic, intense sympathetic blockade is considered among the causes of vasovagal syncope during spinal or epidural anesthesia. The main aim of this research is to determine the anxiety levels of patients undergoing spinal anesthesia before surgery and to investigate the effect of this anxiety level on vasovagal events that may be observed during spinal anesthesia.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Vasovagal Events During Spinal Anesthesia	T1: in the preoperative period, T2: during anesthesia, T3: in the first 5 minutes after anesthesia	Vasovagal event is defined as the occurence of braycardia(heart rate\<50) or hypotension(systolic blood pressure decrease \>%30 from baseline symptoms such as nausea, dizziness, transient loss of conciouness.

Secondary

Measure	Time frame	Description
Preoperative anxiety scale	Preoperative period	During the preoperative period, the patient's anxiety level will be measured using the Amsterdam Preoperative Anxiety Scale.
non-invasive mean arterial pressure	T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over	—
Heart Rate	T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over	—

Countries

Turkey (Türkiye)

Contacts

CONTACTVeysi YAZAR

yazar_2202@hotmail.com+905422216333

CONTACTAbdulhakim ŞENGEL

ahsengel121@gmail.com+905374030916

PRINCIPAL_INVESTIGATORVeysi YAZAR

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Outcome results