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

April 22, 2026 updated by: VEYSİ YAZAR, Sanliurfa Mehmet Akif Inan Education and Research Hospital
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Sanliurfa, Turkey (Türkiye)
        • Recruiting
        • Şanlıurfa Mehmet Akif İnan Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients aged 18-65 years, classified as ASA physical status I-II, who are scheduled to undergo elective surgical procedures under spinal anesthesia at Mehmet Akif Inan Education and Research Hospital. Patients will be recruited consecutiveyl during the study period. Preoperative anxiety levels will be assesed prior to spinal anesthesia and participants will be monitored intraoperatively for the occurence of vasovagal events.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Spinal Anesthesia Patients
Adult patients undergoing elective surgery under spinal anesthesia. Preoperative anxiety levels will be assessed and the incidence of vasovagal events during spinal anesthesia will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
T1: in the preoperative period, T2: during anesthesia, T3: in the first 5 minutes after anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperative period
non-invasive mean arterial pressure
Time Frame: T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over
T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over
Heart Rate
Time Frame: T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over
T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over

Other Outcome Measures

Outcome Measure
Time Frame
The effect of fasting duration on vasovagal syncope
Time Frame: Preoperative period
Preoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Investigators

  • Principal Investigator: Veysi YAZAR, Sanliurfa Mehmet Akif Inan Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PASAVV26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethics committee approval covers only aggregate data analysis; there is no permission to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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