Overview
Sponsor-declared trial summary
Preoperative anxiety
To evaluate the persistence of the preoperative anxiolytic effect of music therapy versus midazolam using electroencephalographic and clinical analysis.
Key facts
- Sponsor
- Consorci Mar Parc De Salut De Barcelona
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2025-12-05
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the persistence of the preoperative anxiolytic effect of music therapy versus midazolam using electroencephalographic and clinical analysis.
Secondary objectives 5
- Evaluate through the analysis of the electroencephalogram (EEG), the degree of anxiolysis with music therapy vs midazolam
- Evaluate by using clinical scales (designed to measure anxiety) the degree of anxiolysis with music therapy vs midazolam
- Record, if any, the onset and intensity of delirium, agitation, respiratory depression and pain
- To study potential differences in terms of the type of surgery (major or minor) or the patient's age
- To examine potential differences in patients who take chronic benzodiazepine.
Conditions and MedDRA coding
Preoperative anxiety
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients who have been scheduled for surgery and have agreed to give informed consent for the study.
Exclusion criteria 6
- Refusal to be part of the study on a voluntary basis
- Patients who report dissatisfaction with music therapy
- Severe hearing loss
- A patient condition that impairs the ability to comprehend the study information.
- A history of allergic reactions to benzodiazepines
- Conditions in which benzodiazepine use is not recommended, such as severe obstructive apnea, morbid obesity, or other relevant conditions considered by an anesthesiologist.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Raw electroencephalogram (EEG) collected with Bispectral Index monitoring (BIG). Bilateral BIS sensors allow to get levels of arousal and valencia
- Scales to measure anxiety:“Preoperative Anxiety and Information Scale (APAIS), The Hospital Anxiety Depression Scale (HADS) and Visual Analogue anxiety Scale (VAS)
Secondary endpoints 1
- Processed EEG (BIS index), blood pressure, heart rate and oxygen saturation, demographics, surgery type (ambulatory vs. admitted patient), adverse effects, chronic use prescriptions
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Midazolam Serraclinics 1 Mg/Ml Solución Inyectable Y Para Perfusión Efg
PRD7392590 · Product
- Active substance
- Midazolam Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CD08 — MIDAZOLAM
- Marketing authorisation
- 65318
- MA holder
- LABORATORIOS SERRA PAMIES S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Consorci Mar Parc De Salut De Barcelona
- Sponsor organisation
- Consorci Mar Parc De Salut De Barcelona
- Address
- Passeig Maritim De La Barceloneta 25-29
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Hospital del Mar
Public contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Hospital del Mar
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo ECM Musicalm Version 2 6 noviembre Publicacion | 1 |
| Protocol (for publication) | 5 Protocolo ECM Musicalm PUBLICACION | 1 |
| Recruitment arrangements (for publication) | 9 Procedimiento y material reclutamiento Musicalm publicacion | 1 |
| Subject information and informed consent form (for publication) | 10 Consentimiento informado musicalm Publicacion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 8 Prospecto Midazolam | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-27 | Spain | Acceptable 2025-12-03
|
2025-12-05 |