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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSanliurfa Mehmet Akif Inan Education and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Soicety of Anesthesiologists (ASA) I-II Patients

18-65 years patients

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants
are grouped into 1 trial group
Group A: Spinal Anesthesia Patients

Trial outcomes

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.

Time frame
T1: in the preoperative period, T2: during anesthesia, T3: in the first 5 minutes after anesthesia

Secondary outcomes

1

Preoperative anxiety scale

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

Time frame
Preoperative period
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

Sponsors and contacts

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