Perioperative Music in Obese Patients Under Spinal Anesthesia

NCT06835101 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-19

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06835101 on ClinicalTrials.gov