Clinical trial • Not applicable • Other
ESMOLOL HYDROCHLORIDE for Laparoscopic cholecystectomy
Not applicable trial of ESMOLOL HYDROCHLORIDE for Laparoscopic cholecystectomy.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Laparoscopic cholecystectomy
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 23-01-2025
- First CTIS Authorization Date
- 16-05-2025
Trial design
Randomised, open-label, sufentanil viatris 5 microgrammes/ml solution injectable; route: injection; dose unit reported as µg/kg with maximum daily/total dose reported as 30 µg/kg (product data).-controlled Not applicable trial across 2 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Sufentanil Viatris 5 microgrammes/ml solution injectable; route: injection; dose unit reported as µg/Kg with maximum daily/total dose reported as 30 µg/Kg (product data).
- Target Sample Size
- 120
Eligibility
Recruits 120 Vulnerable populations: patients deprived of liberty and patients under guardianship/curatorship are excluded. Trial enrols adult patients only. Informed consent must be signed by the patient ("Patient having signed their consent"). No paediatric participants or assent processes are indicated; isVulnerablePopulationSelected is false..
- Pregnancy Exclusion
- - Pregnant or breastfeeding woman
- Vulnerable Population
- Vulnerable populations: patients deprived of liberty and patients under guardianship/curatorship are excluded. Trial enrols adult patients only. Informed consent must be signed by the patient ("Patient having signed their consent"). No paediatric participants or assent processes are indicated; isVulnerablePopulationSelected is false.
Inclusion criteria
- {"criterion_text":"- Adult patient\n- ASA I to III\n- Planned outpatient cholecystectomy\n- General anesthesia with orotracheal intubation\n- Patient having signed their consent\n- Patient affiliated to a social security system"}
Exclusion criteria
- {"criterion_text":"- Patient on Beta-blockers\n- Uncontrolled high blood pressure\n- Contraindication to beta-blockers: in particular conduction disorders with BAV2 or 3, bradycardia with HR < 50 bpm\n- Hypersensitivity to the active substance or to any of the excipients of sufentanil and Esmolol\n- 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\n- Difficult expected intubation during anesthesia consultation\n- Severe obesity (BMI > 35 kg/m2)\n- Pregnant or breastfeeding woman\n- Patients deprived of liberty\n- Patient under guardianship/curatorship"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Quality of recovery questionnaire (fQoR-15) on D1 (day after surgery)","definition_or_measurement_approach":"Measured using the fQoR-15 questionnaire on Day 1 (the day after surgery)."}
Secondary endpoints
- {"endpoint_text":"- Cumulative duration of the Visual Analogue Scale (VAS) > 3 and total dose of morphine\n- Presence of pharyngeal pain (= sore throat) in the recovery room and outpatient\n- Blood pressure surge with SBP > 180 mmHg and/or DBP > 110 mmHg\n- Tachycardia with HR > 100 bpm\n- Hypotension with SBP < 90 mmHg and/or DBP < 50 mmHg\n- Bradycardia with HR < 50 bpm\n- Use of vasopressors intraoperatively","definition_or_measurement_approach":"Endpoints include thresholds and measures as specified: cumulative duration with VAS > 3 and total morphine dose; presence of pharyngeal pain (sore throat) in recovery room and outpatient; hemodynamic events defined by given SBP/DBP and HR thresholds; and intraoperative vasopressor use."}
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent must be signed by the patient (adult). Subject information and informed consent form documents are listed (L1_SIS_patient...); no paediatric assent procedures or languages are specified in the available record.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 120
France
- Latest Decision Or Authorization Date
- 07-04-2026
- Number Of Sites
- 2
- Number Of Participants
- 120
Sites
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Anesthesia
- Principal Investigator Name
- Alexandre DAMON
- Principal Investigator Email
- alexandre.damon@chu-limoges.fr
- Contact Person Name
- Alexandre DAMON
- Contact Person Email
- alexandre.damon@chu-limoges.fr
- Site Name
- Centre Hospitalier De Brive
- Department Name
- Anesthesia
- Principal Investigator Name
- Romain NIEUVIARTS
- Principal Investigator Email
- romain.nieuviarts@ch-brive.fr
- Contact Person Name
- Romain NIEUVIARTS
- Contact Person Email
- romain.nieuviarts@ch-brive.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Et Universitaire De Limoges
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- ESMOCARD 100 mg/10 ml, solution injectable
- Active Substance
- ESMOLOL HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Authorised (marketing authorisation details present in product record)
- Maximum Dose
- maxDailyDoseAmount 100 µg/Kg; maxTotalDoseAmount 300 µg/Kg (doseUom: µg/Kg)
- Investigational Product Name
- Sufentanil Viatris 5 microgrammes/ml solution injectable
- Active Substance
- SUFENTANIL CITRATE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Authorised (marketing authorisation details present in product record)
- Maximum Dose
- maxDailyDoseAmount 30 µg/Kg; maxTotalDoseAmount 30 µg/Kg (doseUom: µg/Kg)
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