NCT06835101Not yet recruitingPhase 2
Perioperative Music in Obese Patients Under Spinal Anesthesia
The Effect of Music Versus Midazolam on Perioperative Anxiety of Obese Patients Under Spinal Anesthesia
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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?
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 15 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Dec 2025
- Lead sponsor
- Asklepieion Voulas General Hospital
- Diseases
- Obesity
- NCT number
- NCT06835101
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From Feb 2025 to the primary completion date, Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- severe psychiatric, cognitive or sensory impairment
- known hypersensitivity to midazolam,
- renal impairment
Other
- absolute contraindications of spinal anaesthesia,
- mother language other than greek,
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asklepieion Hospital of Voula Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| General Hospital of Kavala Coordinator of this site? Confirm its status | Kavala | Greece | Unknown status |
| General Hopsital of Rethymno Coordinator of this site? Confirm its status | Rethymno | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.