Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
120
Countries
1
Sites
2
Laparoscopic Cholecystectomy
To evaluate whether the use of Esmolol is equivalent to the use of Sufentanil for patient comfort, assessed on the quality of recovery, after anesthesia with oro-tracheal intubation for laparoscopic cholecystectomy by a randomized trial.
Key facts
- Sponsor
- Centre Hospitalier Et Universitaire De Limoges
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07]
- Trial duration
- 23 Oct 2025 → ongoing
- Decision date (initial)
- 2025-05-16
- 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, Efficacy
To evaluate whether the use of Esmolol is equivalent to the use of Sufentanil for patient comfort, assessed on the quality of recovery, after anesthesia with oro-tracheal intubation for laparoscopic cholecystectomy by a randomized trial.
Secondary objectives 1
- Exploring the equivalence between Esmolol and Sufentanil on chronic pain and on the measurement of health status from the patient's perspective at a distance
Conditions and MedDRA coding
Laparoscopic Cholecystectomy
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adult patient - ASA I to III - Planned outpatient cholecystectomy - General anesthesia with orotracheal intubation - Patient having signed their consent - Patient affiliated to a social security system
Exclusion criteria 1
- - Patient on Beta-blockers - Uncontrolled high blood pressure - Contraindication to beta-blockers: in particular conduction disorders with BAV2 or 3, bradycardia with HR < 50 bpm - Hypersensitivity to the active substance or to any of the excipients of sufentanil and Esmolol - Pre-existing hemodynamic abnormality: HR < 50bpm and/or SBP < 90 mmHg and/or DBP < 50 mmHg and/or HR > 100 and/or SBP > 180 mmHg and/or DBP > 110 mmHg - Difficult expected intubation during anesthesia consultation - Severe obesity (BMI > 35 kg/m2) - Pregnant or breastfeeding woman - Patients deprived of liberty - Patient under guardianship/curatorship
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Quality of recovery questionnaire (fQoR-15) on D1 (day after surgery)
Secondary endpoints 1
- 1- Cumulative duration of the Visual Analogue Scale (VAS) > 3 and total dose of morphine 2-Presence of pharyngeal pain (= sore throat) in the recovery room and outpatient 3- Blood pressure surge with SBP > 180 mmHg and/or DBP > 110 mmHg 4- Tachycardia with HR > 100 bpm 5- Hypotension with SBP < 90 mmHg and/or DBP < 50 mmHg ), bradycardia with HR < 50 bpm ; Use of vasopressors intraoperatively
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
ESMOCARD 100 mg/10 ml, solution injectable
PRD469345 · Product
- Active substance
- Esmolol Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 100 µg/Kg microgram(s)/kilogram
- Max total dose
- 300 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07AB09 — ESMOLOL
- Marketing authorisation
- 34009 570 957 1 0
- MA holder
- ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Sufentanil Viatris 5 microgrammes/ml solution injectable
PRD10933526 · Product
- Active substance
- Sufentanil Citrate
- Substance synonyms
- 2-HYDROXYPROPANE-1,2,3-TRICARBOXYLIC ACID, N-[4-(METHOXYMETHYL)-1-(2-THIOPHEN-2-YLETHYL)-4-PIPERIDYL]-N-PHENYL-PROPANAMIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 30 µg/Kg microgram(s)/kilogram
- Max total dose
- 30 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH03 — SUFENTANIL
- Marketing authorisation
- BE288547
- MA holder
- VIATRIS GX
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Et Universitaire De Limoges
- Sponsor organisation
- Centre Hospitalier Et Universitaire De Limoges
- Address
- 2 Avenue Martin Luther King
- City
- Limoges Cedex 1
- Postcode
- 87042
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Et Universitaire De Limoges
- Contact name
- Chef de Projet
Public contact point
- Organisation
- Centre Hospitalier Et Universitaire De Limoges
- Contact name
- Chef de Projet
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 120 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier De Brive
Anesthesia, 1 Boulevard Du Docteur Verlhac, 19100, Brive La Gaillarde
Centre Hospitalier Et Universitaire De Limoges
Anesthesia, 2 Avenue Martin Luther King, 87000, Limoges
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 |
|---|---|---|---|---|---|
| France | 2025-10-23 | 2025-10-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 19 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_2024-520282-31_unblinded_TC | 2 |
| Protocol (for publication) | D1_Protocol_2024-520282-31 | 2 |
| Protocol (for publication) | D1_Protocol_2024-520282-31_TC | 2 |
| Protocol (for publication) | D1_Protocol_2024-520282-31_TC | 2 |
| Protocol (for publication) | D1_Protocol_2024-520282-31_unblinded | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | L3_Questionnaire FQoR_TC | 1 |
| Recruitment arrangements (for publication) | L3_Questionnaire_ DN2 | 1 |
| Recruitment arrangements (for publication) | L3_Questionnaire_ WHODAS-2 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_patient_2024-520282-31 | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_patient_2024-520282-31_TC | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_patient_2024-520282-31L1_SIS_patient_2024-520282-31 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_patient_2024-520282-31L1_SIS_patient_2024-520282-31_TC | 1 |
| Subject information and informed consent form (for publication) | L3_Questionnaire FQoR | 2 |
| Subject information and informed consent form (for publication) | MODIFICATIONS_ RFI-CT-2024-520282-31-00-IN-003 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC SUFENTANIL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-520282-31 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-520282-31 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-520282-31_TC | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-23 | France | Acceptable 2025-05-13
|
2025-05-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-25 | France | Acceptable 2026-03-16
|
2026-04-07 |