Perioperative Music in Obese Patients Under Spinal Anesthesia

Asklepieion Voulas General Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Obesity, Adolescent

Treatments: Other: Music intervention; Drug: Midazolam (sedative)

Study type: Interventional

Funder types: Other

Identifiers

NCT06835101

25870/9-10-24

Details and patient eligibility

About

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?

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• absolute contraindications of spinal anaesthesia,
• severe psychiatric, cognitive or sensory impairment
• mother language other than greek,
• known hypersensitivity to midazolam,
• renal impairment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Music group

Active Comparator group

Description:

The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.

Treatment:

Other: Music intervention

Midazolam group

Active Comparator group

Description:

The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.

Treatment:

Drug: Midazolam (sedative)