Clinical trial • Not applicable • Other
Midazolam hydrochloride for Preoperative anxiety
Not applicable trial of Midazolam hydrochloride for Preoperative anxiety.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Preoperative anxiety
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-08-2025
- First CTIS Authorization Date
- 05-12-2025
Trial design
Midazolam (MIDAZOLAM SERRACLINICS 1 mg/ml SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EFG), intravenous administration; maximum total dose indicated 1 mg. Comparator: music therapy (non-pharmacological).-controlled Not applicable trial across 1 site in Spain.
- Comparator
- Midazolam (MIDAZOLAM SERRACLINICS 1 mg/ml SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EFG), intravenous administration; maximum total dose indicated 1 mg. Comparator: music therapy (non-pharmacological).
- Target Sample Size
- 100
- Trial Duration For Participant
- 1
Eligibility
Recruits 100 Vulnerable populations not selected; participants must provide informed consent. No assent procedures or specific consent handling for minors or other vulnerable groups are specified..
- Vulnerable Population
- Vulnerable populations not selected; participants must provide informed consent. No assent procedures or specific consent handling for minors or other vulnerable groups are specified.
Inclusion criteria
- {"criterion_text":"- Patients who have been scheduled for surgery and have agreed to give informed consent for the study."}
Exclusion criteria
- {"criterion_text":"- Refusal to be part of the study on a voluntary basis"}
- {"criterion_text":"- Patients who report dissatisfaction with music therapy"}
- {"criterion_text":"- Severe hearing loss"}
- {"criterion_text":"- A patient condition that impairs the ability to comprehend the study information."}
- {"criterion_text":"- A history of allergic reactions to benzodiazepines"}
- {"criterion_text":"- 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 endpoints
- {"endpoint_text":"- Raw electroencephalogram (EEG) collected with Bispectral Index monitoring (BIG). Bilateral BIS sensors allow to get levels of arousal and valencia","definition_or_measurement_approach":"Raw EEG collected using Bispectral Index (BIS) monitoring; bilateral BIS sensors used to obtain levels of arousal and valence."}
- {"endpoint_text":"- Scales to measure anxiety:“Preoperative Anxiety and Information Scale (APAIS), The Hospital Anxiety Depression Scale (HADS) and Visual Analogue anxiety Scale (VAS)","definition_or_measurement_approach":"Clinical anxiety assessed using APAIS, HADS and Visual Analogue Scale (VAS) instruments."}
Secondary endpoints
- {"endpoint_text":"- Processed EEG (BIS index), blood pressure, heart rate and oxygen saturation, demographics, surgery type (ambulatory vs. admitted patient), adverse effects, chronic use prescriptions","definition_or_measurement_approach":"Processed EEG reported as BIS index; vital signs (blood pressure, heart rate, oxygen saturation) recorded; collection of demographics, surgery type, adverse events and chronic medication use."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 3
- Consent Approach
- Informed consent required from participants: inclusion criterion states participants must have agreed to give informed consent. Subject information and informed consent form available (document titled '10 Consentimiento informado musicalm Publicacion'). No details on assent, age‑specific consent procedures, or languages specified in the record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
Spain
- Earliest CTIS Part Ii Submission Date
- 10-06-2025
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 178
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Consorci Mar Parc De Salut De Barcelona
- Department Name
- Anestesiologia, Reanimación y Terapeutica del Dolor
- Contact Person Name
- Juan Fernandez Candil
- Contact Person Email
- jfernandezc@hmar.cat
- Number Of Participants
- 100
Sponsor
Primary sponsor
- Full Name
- Consorci Mar Parc De Salut De Barcelona
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- MIDAZOLAM SERRACLINICS 1 mg/ml SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EFG
- Active Substance
- Midazolam hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation holder: LABORATORIOS SERRA PAMIES S.A.; Marketing authorisation number 65318 (authorised in Spain)
- Maximum Dose
- 1 mg
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