Overview
Sponsor-declared trial summary
Patients undergoing vitrectomy and/or cataract surgery
To investigate the effect of music on perioperative pain. To investigate the effect of herbal medicine on perioperative pain.
Key facts
- Sponsor
- Medical University Of Graz
- 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]
- Trial duration
- 19 Nov 2025 → ongoing
- Decision date (initial)
- 2025-11-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To investigate the effect of music on perioperative pain. To investigate the effect of herbal medicine on perioperative pain.
Secondary objectives 1
- To investigate an association between classical music and perioperative anxiety. To investigate an association between herbal medicine and perioperative anxiety. To investigate an association between speed rate of retrobulbar injection and pain
Conditions and MedDRA coding
Patients undergoing vitrectomy and/or cataract surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10007739 | Cataract | 100000004853 |
| 20.0 | PT | 10047644 | Vitrectomy | 100000004865 |
| 20.0 | LLT | 10069129 | Pars plana vitrectomy | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Subjects above 18 years.
- Capable of providing informed consent.
- Requiring pars plana vitrectomy or cataract surgery on one eye only
Exclusion criteria 4
- Any abnormalities preventing reliable measurement as judged by the investigator.
- Psychotropic drug intake as long-term daily therapy.
- High grade hearing impairment.
- Pregnancy or breast-feeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- NRS-P score 30 seconds after retrobulbar block.
Secondary endpoints 1
- STAI Questionnaire at admission; NRS-P and NRS-A before retrobulbar injection; NRS-P score 30 seconds after retrobulbar block; NRS-P and NRS-A score directly after operation; Speed rate/duration of retrobulbar injection
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD5553156 · Product
- Active substance
- Lupuli Flos Dry Alcoholic Extract
- Substance synonyms
- LUPULI FLOS EXTRACTUM SPIRITUOSUM SICCUM
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 1 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CX — HYPNOTICS AND SEDATIVES IN COMBINATION, EXCL. BARBITURATES
- Marketing authorisation
- 736028
- MA holder
- M.C.M. KLOSTERFRAU HEALTHCARE GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Bromazepam Genericon 3 mg Filmtabletten
PRD301769 · Product
- Active substance
- Bromazepam
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1.5 mg milligram(s)
- Max total dose
- 1.5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05BA08 — BROMAZEPAM
- Marketing authorisation
- 1-19858
- MA holder
- GENERICON PHARMA GESELLSCHAFT M.B.H.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Graz
- Sponsor organisation
- Medical University Of Graz
- Address
- Neue Stiftingtalstrasse 6
- City
- Graz
- Postcode
- 8010
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Graz
- Contact name
- Karin Brandner
Public contact point
- Organisation
- Medical University Of Graz
- Contact name
- Karin Brandner
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 240 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-11-19 | 2025-12-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-520132-15-00_redacted | 2 |
| Protocol (for publication) | D1_Protocol_2024-520132-15-00_reducted | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master_reducted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material questionaire STAI | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material scales NRS-A_NRS-P | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bromazepam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nervenruh forte | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DE_2024-520132-15-00 | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-05 | Austria | Acceptable 2025-11-03
|
2025-11-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-05 | Austria | Acceptable 2025-11-03
|
2025-12-05 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-02 | Austria | Acceptable 2025-11-03
|
2026-02-02 |