Spinal AnesthesiaNCT07450014
The Effect of Preoperative Anxiety Level on Vasovagal Events During Spinal Anesthesia and the Incidence of Vasovagal Events
An observational study of Spinal Anesthesia and Anxiety, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Anesthesia, Anxiety
- How many people
- 1,500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- American Soicety of Anesthesiologists (ASA) I-II Patients
- 18-65 years patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şanlıurfa Mehmet Akif İnan Training and Research Hospital
Sanliurfa
Veysi YAZAR, MD, +905422216333, yazar_2202@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Spinal Anesthesia, Anxiety
- Keywords
- Amsterdam Preoperative Anxiety and Information Scale, sencop
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1: in the preoperative period, T2: during anesthesia, T3: in the first 5 minutes after anesthesia
Secondary outcomes (3)
Preoperative anxiety scale
During the preoperative period, the patient's anxiety level will be measured using the Amsterdam Preoperative Anxiety Scale.
Measured: Preoperative period
non-invasive mean arterial pressure
Measured: T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over
Heart Rate
Measured: T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start15 Apr 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VEYSİ YAZAR, Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Investigators
- Veysi YAZAR, Principal investigator, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450014
- Sponsor's protocol ID
- PASAVV26
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethics committee approval covers only aggregate data analysis; there is no permission to share individual participant data
Publications
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.
PubMed 9893544Kinsella 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.
PubMed 11573596Liu SS, McDonald SB. Current issues in spinal anesthesia. Anesthesiology. 2001 May;94(5):888-906. doi: 10.1097/00000542-200105000-00030. No abstract available.
PubMed 11388543
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Anxiety Level on Vasovagal Events During Spinal Anesthesia and the Incidence of Vasovagal Events
- ClinicalTrials.gov ID
- NCT07450014
- Acronym / sponsor ID
- PASAVV26
- Conditions
- Spinal Anesthesia, Anxiety
- Keywords
- Amsterdam Preoperative Anxiety and Information Scale, sencop
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- American Soicety of Anesthesiologists (ASA) I-II Patients
- 18-65 years patients
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Preoperative anxiety scale
Time frame: 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
Heart Rate
Time frame: T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Results publication: PubMed 9893544Hart 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.
- Results publication: PubMed 11573596Kinsella 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.
- Results publication: PubMed 11388543Liu SS, McDonald SB. Current issues in spinal anesthesia. Anesthesiology. 2001 May;94(5):888-906. doi: 10.1097/00000542-200105000-00030. No abstract available.
- Individual participant dataSharing planned: No. Ethics committee approval covers only aggregate data analysis; there is no permission to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Veysi YAZAR principal investigator
Sanliurfa Mehmet Akif Inan Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia and Anxiety, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veysi YAZAR (+905422216333, yazar_2202@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07450014, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.