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NCT Number: NCT07450014

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Şanlıurfa Mehmet Akif İnan Training and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location status: Recruiting

Location contact

Veysi YAZAR, MD

CONTACT

[email protected]

+905422216333

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Incidence of Vasovagal Events During Spinal Anesthesia

    Time frame: 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 outcomes

  1. Preoperative anxiety scale

    Time frame: Preoperative period

    During the preoperative period, the patient's anxiety level will be measured using the Amsterdam Preoperative Anxiety Scale.

  2. non-invasive mean arterial pressure

    Time frame: T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over

  3. Heart Rate

    Time frame: T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over

Other outcomes

  1. The effect of fasting duration on vasovagal syncope

    Time frame: Preoperative period

Study contacts

Contact information is provided by the study sponsor or research team.

Abdulhakim ŞENGEL

CONTACT

[email protected]

+905374030916

Veysi YAZAR

CONTACT

[email protected]

+905422216333

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Apr 28, 2026

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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