Laparoscopic Cholecystectomy SurgeryPhase 4ESANCT07019818
Esmolol Versus Sufentanil on the Quality of Post-cholecystectomy Recovery Laparoscopic Anaesthesia With Orotracheal Intubation on an Outpatient Basis
A Phase 4 study testing Esmolol Hcl 10Mg/Ml Inj and Sufentanil 5 mcg in people with Laparoscopic Cholecystectomy Surgery, run by University Hospital, Limoges at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery
- What is being tested?
- Esmolol Hcl 10Mg/Ml Inj and Sufentanil 5 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Oct 2025to 5 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Severe obesity (BMI > 35 kg/m2)
- Pregnant or breast-feeding women
- Patients deprived of liberty
- Patients under guardianship
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CH Brive
Brive-la-Gaillarde, France, 19100
Romain NIEUVIARTS, Physician, 05 55 92 60 00, ROMAIN.NIEUVIARTS@ch-brive.fr
- Recruiting
CHU Limoges
Limoges, France, 87042
Alexandre DAMON, Physician, 05 55 05 55 55, Alexandre.DAMON@chu-limoges.fr
About this study
Official title: Esmolol Versus Sufentanil on the Quality of Recovery After Laparoscopic Cholecystectomy During Anaesthesia With Orotracheal Intubation on an Outpatient Basis
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. As with other morphine-based analgesics (painkillers), sufentanil can be associated with nausea and vomiting, confusion, itching and addiction.
Read more
There is an approach to anaesthesia which aims to eliminate the use of morphine in order to avoid its side effects, but there is a lack of clinical trials and benchmarks to provide proof of this.
Esmolol is a cardioselective beta-blocker (a substance that acts only on the heart) which also has marketing authorisation for all types of surgery, the most frequent side effects of which are hypotension and bronchospasm.
These two drugs have different therapeutic properties for a common objective under general anaesthesia, namely the stability of vital parameters (such as pulse, blood pressure, blood oxygenation, etc.) during surgery.
Esmolol disappears very quickly from the body, which could give it an interesting place in outpatient management.
The hypothesis tested in this study is that the use of Esmolol is an effective alternative to Sufentanil during general anaesthesia for laparoscopic cholecystectomy with orotracheal intubation on the quality of post-operative recovery and pain.
The aim of this study is to evaluate whether the use of Esmolol is equivalent to the use of Sufentanil in terms of patient comfort, assessed in terms of quality of recovery, after general anaesthesia with orotracheal intubation for laparoscopic cholecystectomy.
Read the detailed description
The study will recruit 120 patients over a period of 18 months. Each patient will participate for two days.
The study is multicentre, which means that patients from several hospitals will be able to take part. Two hospitals will be taking part: Brive La Gaillarde Hospital and Limoges University Hospital.
The aim of this equivalence study is to compare Esmolol with Sufentanil. If you agree, and after the study doctor has checked the inclusion criteria and provided you with information, you will sign a consent form.
In this study, we are going to compare two different anaesthetic treatments:
- Group 1: use of Esmolol
- Group 2: use of Sufentanil Regardless of the group, as part of this study, you will receive one day's follow-up which will consist of a single visit by telephone by a member of the team, during which you will be asked to complete a short questionnaire on the quality of recovery the day after your surgery and you will also be asked about your consumption of painkillers at home.
This research is open to all adult patients, in good health or suffering from a mild or severe non-life-threatening condition, scheduled for laparoscopic cholecystectomy as an outpatient, under general anaesthetic with orotracheal intubation (which consists of placing a tube in the trachea through the glottic orifice, with the upper end emerging through the mouth, a routine procedure in the operating theatre).
Unfortunately, however, you cannot take part if you are taking beta-blockers or if you have any contraindications to taking beta-blockers; or if you have uncontrolled hypertension or abnormal vital parameters (pulse, blood pressure); or if you are expected to have difficulty intubating during the anaesthetic consultation, or if you are severely obese. You may also not take part if you are pregnant or breastfeeding, or if you are hypersensitive to the active substance or to any of the excipients of sufentanil and esmolol, or if you are under guardianship or deprived of your liberty.
You will receive a medical examination during your anaesthetic consultation. Participating patients must be affiliated to a social security scheme.
If you take part in this research, there will be three visits:
- An inclusion visit, which will take place during your anaesthetic consultation, where the investigating doctor will check the eligibility criteria and collect your written consent to take part. Data will be collected: age, sex, comorbidities (obstructive ventilatory disorders (asthma/BPCO) and opiate addiction), clinical characteristics such as weight, height, BMI, ASA score, heart rate, blood pressure.
- A 2nd visit on the day of your surgery, when the investigating doctor will double-check certain eligibility criteria (use of beta-blockers, cancelled cholecystectomy, pregnancy) and then draw lots by computer to decide which group you will be in (group 1: esmolol or group 2: sufentanil), with vital parameters recorded.
- A 3rd and final visit the day after your surgery, during which a quality of recovery questionnaire (15 questions) will be completed over the telephone by a member of the team, as well as an assessment of your consumption of painkillers at home.
You will not know which group you are in, so as not to influence your answers to the quality of recovery questionnaire carried out by telephone the day after your surgery; nor will the person who contacts you to ask you the questions. However, your doctor will know which group you are in.
Your doctor must provide you with all the necessary explanations concerning this research. If you wish to withdraw at any time, for whatever reason, you will continue to benefit from medical monitoring and this will in no way affect your future surveillance.
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Being tested
- Esmolol Hcl 10Mg/Ml Inj, Sufentanil 5 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol Hcl 10Mg/Ml InjDrug
Esmolol is an injectable cardioselective beta-blocker, preferentially inhibiting beta-1 adrenergic receptors, while avoiding an increase in peripheral vascular resistance.
Sufentanil 5 mcgDrug
Sufentanil is a synthetic opioid with the pharmacological properties of a µ-receptor agonist.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (experimental arm) | Experimental | Esmolol 1 à 1,5 mg/kg at induction Receives: Drug: Esmolol Hcl 10Mg/Ml Inj |
| Group 2 (comparator arm) | Active comparator | Sufentanil 0,1 à 0,3 μg /kg at induction. Receives: Drug: Sufentanil 5 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Describe the difference in quality of recovery using the questionnaire
To estimate the difference in the quality of recovery score (fQoR-15) at D1 between the two randomisation groups (Esmolol versus Sufentanil), as well as its 95% confidence interval.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start29 Oct 2025
- Primary completion4 Jan 2028 (estimated)
- Study completion5 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019818
- Sponsor's protocol ID
- 87RI_24_0041 - ESA
- Other IDs
- 2024-520282-31-00
- Acronym
- ESA
- Status last verified
- Apr 2026
- First submitted
- 13 May 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esmolol Versus Sufentanil on the Quality of Recovery After Laparoscopic Cholecystectomy During Anaesthesia With Orotracheal Intubation on an Outpatient Basis
- ClinicalTrials.gov ID
- NCT07019818
- Acronym / sponsor ID
- ESA / 87RI_24_0041 - ESA
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 4 Jan 2028 (estimated)
- Study completion
- 5 Jan 2028 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. As with other morphine-based analgesics (painkillers), sufentanil can be associated with nausea and vomiting, confusion, itching and addiction.
There is an approach to anaesthesia which aims to eliminate the use of morphine in order to avoid its side effects, but there is a lack of clinical trials and benchmarks to provide proof of this.
Esmolol is a cardioselective beta-blocker (a substance that acts only on the heart) which also has marketing authorisation for all types of surgery, the most frequent side effects of which are hypotension and bronchospasm.
These two drugs have different therapeutic properties for a common objective under general anaesthesia, namely the stability of vital parameters (such as pulse, blood pressure, blood oxygenation, etc.) during surgery.
Esmolol disappears very quickly from the body, which could give it an interesting place in outpatient management.
The hypothesis tested in this study is that the use of Esmolol is an effective alternative to Sufentanil during general anaesthesia for laparoscopic cholecystectomy with orotracheal intubation on the quality of post-operative recovery and pain.
The aim of this study is to evaluate whether the use of Esmolol is equivalent to the use of Sufentanil in terms of patient comfort, assessed in terms of quality of recovery, after general anaesthesia with orotracheal intubation for laparoscopic cholecystectomy.
Detailed description
The study will recruit 120 patients over a period of 18 months. Each patient will participate for two days.
The study is multicentre, which means that patients from several hospitals will be able to take part. Two hospitals will be taking part: Brive La Gaillarde Hospital and Limoges University Hospital.
The aim of this equivalence study is to compare Esmolol with Sufentanil. If you agree, and after the study doctor has checked the inclusion criteria and provided you with information, you will sign a consent form.
In this study, we are going to compare two different anaesthetic treatments:
- Group 1: use of Esmolol
- Group 2: use of Sufentanil Regardless of the group, as part of this study, you will receive one day's follow-up which will consist of a single visit by telephone by a member of the team, during which you will be asked to complete a short questionnaire on the quality of recovery the day after your surgery and you will also be asked about your consumption of painkillers at home.
This research is open to all adult patients, in good health or suffering from a mild or severe non-life-threatening condition, scheduled for laparoscopic cholecystectomy as an outpatient, under general anaesthetic with orotracheal intubation (which consists of placing a tube in the trachea through the glottic orifice, with the upper end emerging through the mouth, a routine procedure in the operating theatre).
Unfortunately, however, you cannot take part if you are taking beta-blockers or if you have any contraindications to taking beta-blockers; or if you have uncontrolled hypertension or abnormal vital parameters (pulse, blood pressure); or if you are expected to have difficulty intubating during the anaesthetic consultation, or if you are severely obese. You may also not take part if you are pregnant or breastfeeding, or if you are hypersensitive to the active substance or to any of the excipients of sufentanil and esmolol, or if you are under guardianship or deprived of your liberty.
You will receive a medical examination during your anaesthetic consultation. Participating patients must be affiliated to a social security scheme.
If you take part in this research, there will be three visits:
- An inclusion visit, which will take place during your anaesthetic consultation, where the investigating doctor will check the eligibility criteria and collect your written consent to take part. Data will be collected: age, sex, comorbidities (obstructive ventilatory disorders (asthma/BPCO) and opiate addiction), clinical characteristics such as weight, height, BMI, ASA score, heart rate, blood pressure.
- A 2nd visit on the day of your surgery, when the investigating doctor will double-check certain eligibility criteria (use of beta-blockers, cancelled cholecystectomy, pregnancy) and then draw lots by computer to decide which group you will be in (group 1: esmolol or group 2: sufentanil), with vital parameters recorded.
- A 3rd and final visit the day after your surgery, during which a quality of recovery questionnaire (15 questions) will be completed over the telephone by a member of the team, as well as an assessment of your consumption of painkillers at home.
You will not know which group you are in, so as not to influence your answers to the quality of recovery questionnaire carried out by telephone the day after your surgery; nor will the person who contacts you to ask you the questions. However, your doctor will know which group you are in.
Your doctor must provide you with all the necessary explanations concerning this research. If you wish to withdraw at any time, for whatever reason, you will continue to benefit from medical monitoring and this will in no way affect your future surveillance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (experimental arm) | Experimental | Drug: Esmolol Hcl 10Mg/Ml InjEsmolol 1 à 1,5 mg/kg at induction |
| Group 2 (comparator arm) | Active comparator | Drug: Sufentanil 5 mcgSufentanil 0,1 à 0,3 μg /kg at induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients
- ASA I to III
- Scheduled outpatient cholecystectomy
- General anesthesia with orotracheal intubation
- Patient with signed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esmolol Hcl 10Mg/Ml InjEsmolol is an injectable cardioselective beta-blocker, preferentially inhibiting beta-1 adrenergic receptors, while avoiding an increase in peripheral vascular resistance. | Drug | Group 1 (experimental arm) |
| Sufentanil 5 mcgSufentanil is a synthetic opioid with the pharmacological properties of a µ-receptor agonist. | Drug | Group 2 (comparator arm) |
Primary outcome
To Describe the difference in quality of recovery using the questionnaire
Time frame: 2 days
To estimate the difference in the quality of recovery score (fQoR-15) at D1 between the two randomisation groups (Esmolol versus Sufentanil), as well as its 95% confidence interval.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esmolol Hcl 10Mg/Ml Inj and Sufentanil 5 mcg in people with Laparoscopic Cholecystectomy Surgery, run by University Hospital, Limoges at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain NIEUVIARTS, Physician (+33555926186, romain.nieuviarts@ch-brive.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Describe the difference in quality of recovery using the questionnaire (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.