Perioperative Music in Obese Patients Under Spinal Anesthesia

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsklepieion Voulas General Hospital

About this trial

The goal of this clinical trial is to learn whether music or midazolam has a greater anxiolytic effect on obese patients undergoing spinal anesthesia. It will also determine the safety of music compared to midazolam in this population (differences in blood pressure, heart rate, oxygen saturation). The main question to answer: Music or midazolam is more effective in reducing anxiety in obese patients under spinal anesthesia?

Eligibility criteria

Qualifiers

patients who are > 18 years old

patients with Body Mass Index -ΒΜΙ>30 kg/m2

patients who will give informed consent in receiving spinal anaesthesia

patients who will give informed consent in participating in the study

Disqualifiers

absolute contraindications of spinal anaesthesia,

severe psychiatric, cognitive or sensory impairment

mother language other than greek,

known hypersensitivity to midazolam,

Trial design

Treatments tested in this trial

  • Music intervention
  • Midazolam (sedative)

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Asklepieion Voulas General Hospital

Lead sponsor

General Hospital of Kavala

Sponsor institution