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Compares treatment options for Laparoscopic Cholecystectomy Surgery
Official title Esmolol Versus Sufentanil on the Quality of Post-cholecystectomy Recovery Laparoscopic Anaesthesia With Orotracheal Intubation on an Outpatient Basis
ClinicalTrials.gov ID: NCT07019818
What this study is testing
What is Esmolol Hcl 10Mg/Ml Inj?
Esmolol Hcl 10Mg/Ml Inj is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for laparoscopic cholecystectomy surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There are 120,000 outpatient laparoscopic cholecystectomies with orotracheal intubation per year in France. Sufentanil is the most commonly used morphine during surgery in France, but morphines have harmful effects when administered for surgery.
- Phase 4: studies an already-approved treatment
- Time commitment: about 18 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients
- ASA I to III
- Scheduled outpatient cholecystectomy
- General anesthesia with orotracheal intubation
- Patient with signed consent
You likely can't join if
- Patients on beta-blockers
- Uncontrolled hypertension
- Contraindication to beta-blockers
- Hypersensitivity to the active substance or to one of the excipients of sufentanil and esmolol
- Pre-existing hemodynamic abnormality
- Intubation planned to be difficult during the anaesthesia consultation
See the full eligibility criteria
- Adult patients
- ASA I to III
- Scheduled outpatient cholecystectomy
- General anesthesia with orotracheal intubation
- Patient with signed consent
- Patient affiliated to a social security scheme
- Patients on beta-blockers
- Uncontrolled hypertension
- Contraindication to beta-blockers
- Hypersensitivity to the active substance or to one of the excipients of sufentanil and esmolol
- Pre-existing hemodynamic abnormality
- Intubation planned to be difficult during the anaesthesia consultation
- Severe obesity (BMI \> 35 kg/m2)
- Pregnant or breast-feeding women
- Patients deprived of liberty
- Patients under guardianship
The study team makes the final eligibility decision.
Where it's taking place
- Brive-la-Gaillarde, France, France
- Limoges, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brive-la-Gaillarde, France, France; Limoges, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.