Perioperative Music in Obese Patients Under Spinal Anesthesia
NCT06835101 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-02-19
Summary
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?
Conditions
- Obesity, Adolescent
Interventions
- OTHER
-
Music intervention
The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.
- DRUG
-
Midazolam (sedative)
The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.
Sponsors & Collaborators
-
Asklepieion Voulas General Hospital
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-28
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- Greece
Study Locations
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