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

NCT07450014 | Recruiting

• 1 other identifier: PASAVV26
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Anxiety

Keywords

Amsterdam Preoperative Anxiety and Information Scale; sencop

Outcome Measures

Primary Outcomes (1)

• Incidence of Vasovagal Events During Spinal 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 Outcomes (3)

• Preoperative anxiety scale

  Preoperative period

• 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

Other Outcomes (1)

• The effect of fasting duration on vasovagal syncope

  Preoperative period

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• American Soicety of Anesthesiologists (ASA) I-II Patients
• years patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead

Study Sites (1)

Şanlıurfa Mehmet Akif İnan Training and Research Hospital

Sanliurfa, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Hart PS, Yanny W. Needle phobia and malignant vasovagal syndrome. Anaesthesia. 1998 Oct;53(10):1002-4. doi: 10.1046/j.1365-2044.1998.00570.x.

  PMID: 9893544 RESULT

• Kinsella SM, Tuckey JP. Perioperative bradycardia and asystole: relationship to vasovagal syncope and the Bezold-Jarisch reflex. Br J Anaesth. 2001 Jun;86(6):859-68. doi: 10.1093/bja/86.6.859.

  PMID: 11573596 RESULT

• Liu SS, McDonald SB. Current issues in spinal anesthesia. Anesthesiology. 2001 May;94(5):888-906. doi: 10.1097/00000542-200105000-00030. No abstract available.

  PMID: 11388543 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Veysi YAZAR

  Sanliurfa Mehmet Akif Inan Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veysi YAZAR

CONTACT

+905422216333; yazar_2202@hotmail.com

Abdulhakim ŞENGEL

CONTACT

+905374030916; ahsengel121@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Of Anesthesiology And Reanimation

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)