Perioperative Music in Obese Patients Under Spinal Anesthesia

NCT ID: NCT06835101

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2025-12-31

Brief Summary

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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?

Detailed Description

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Conditions

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Obesity, Adolescent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Music group

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

Group Type ACTIVE_COMPARATOR

Music intervention

Intervention Type OTHER

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

Midazolam group

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

Group Type ACTIVE_COMPARATOR

Midazolam (sedative)

Intervention Type DRUG

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

Interventions

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Music intervention

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

Intervention Type OTHER

Midazolam (sedative)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asklepieion Voulas General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Maria Diakomi

Consultant Anaesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asklepieion Hospital of Voula

Athens, Voula, Greece

Site Status

General Hospital of Kavala

Kavala, , Greece

Site Status

General Hopsital of Rethymno

Rethymno, , Greece

Site Status

Countries

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Greece

Central Contacts

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Alexandros Makris, PhD

Role: CONTACT

00306947076446

Maria Diakomi, PhD

Role: CONTACT

00306948886101

Other Identifiers

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25870/9-10-24

Identifier Type: -

Identifier Source: org_study_id

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