Laparoscopic SurgeryPneumandTOFNCT07005518
Study of the Relationship Between Curarization and Pneumoperitoneum in Laparoscopic Surgery
An observational study of Laparoscopic Surgery and Neuromuscular Blocking Agents, run by Poitiers University Hospital.
Trial summary
The number of surgical procedures is increasing worldwide (1). Laparoscopic surgery is one of the surgical techniques that has become indispensable. Laparoscopic surgery is less invasive than laparotomy. Laparoscopic surgery is performed in several stages, one of which involves the creation of a peritoneal detachment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgery, Neuromuscular Blocking Agents, Pneumoperitoneum
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Nov 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
Study population: Non-inclusion criteria: patients whose anesthetic maintenance is performed with Propofol IACP, patients who have undergone more than 3 intra-abdominal surgical procedures, patients with conversion to laparotomy.
Major patient, operated on by robot-assisted laparoscopic surgery, by two surgeons targeted for their similar working surgical technique.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The number of surgical procedures is increasing worldwide (1). Laparoscopic surgery is one of the surgical techniques that has become indispensable. Laparoscopic surgery is less invasive than laparotomy. Laparoscopic surgery is performed in several stages, one of which involves the creation of a peritoneal detachment. This detachment is achieved by the addition of a gas (CO2), which requires total relaxation of the abdominal muscle fibers. To achieve this, it is advisable to administer a muscle relaxant called curare (2). Curare-induced neuromuscular block, its depth and its release must be monitored during surgery. Curares act as acetylcholine antagonists, inducing neuromuscular block by competing with this neurotransmitter. In France, only one type of device, called an accelerometer, is used to monitor curarization. This device couples electrical stimulation of a nerve with an accelerometer. Curarization can be said to be deep, moderate, residual or absent. Despite curarization appearing deep to the accelerometer, operating conditions do not always seem ideal for abdominal contraction. Indeed, the muscles tested with this device do not concern the muscles involved in laparoscopic surgery.
A currently unexploited surgical parameter, variation in insufflation pressure, could change our approach to intraoperative curarization.
Read the detailed description
Curarization is a fundamental part of surgical management. The administration of these drugs enables intubation and facilitates surgical work. However, these molecules need to be monitored at every stage, from anesthetic induction to patient awakening. Today, a single device is used in operating theatres to monitor the depth of patient curarization. This tool is used on a daily basis, and its use is strongly recommended by the various learned societies associated with anesthesia. Its use in operating theatres is compulsory by law. The device is used either on the ulnar nerve, generating a contraction of the adductor muscle of the thumb, or on the facial nerve, generating a contraction of the orbicularis muscle of the eye. This reflects the curarization of the laryngeal and diaphragmatic muscles. The device delivers repetitive electrical stimulation to these nerves, producing a muscle contraction. The number of muscle contractions in response to these stimulations, and the strength developed by the fourth response compared with the first, indicates the depth of curarization. These measurements are called a train of four.
While performing a train-of-four on the thumb adductor produces measured, quantifiable data, this is absolutely not the case for the orbicularis of the eye, which provides only crude, unreliable data intraoperatively.
Laparoscopic surgery, on the other hand, is a minimally invasive technique that has become increasingly popular in recent decades. It requires deep intraoperative curarization.
This surgical technique can be used for a wide range of urological, visceral and gynecological procedures.
During laparoscopic surgery, insufflation pressure is delivered via trocars into the patient's abdominal cavity. This pressure comes from a column supplied via a carbon dioxide (CO2) cylinder. Initially, a pressure is generated and adjusted at the surgeon's request (3). This pressure creates a space known as the pneumoperitoneum. In the event of insufficient pneumoperitoneum to enable surgery to be performed under optimum conditions, potentially due to a lack of deep curarization, the insufflation pressure is increased at the surgeon's request. This surgical technique is nonetheless prone to causing significant projected pain. As Madsen's study (4) suggests, lowering the insufflation pressure could therefore result in less pain.
By hypothesizing that imperfect curarization would lead to contraction of the abdominal muscles, generating intra-abdominal overpressure. This study investigates the role of intra-abdominal pressure variation in laparoscopic surgery and its correlation with the accelerometer used in current practice. If this hypothesis proves to be true, the expected benefits would be improved operating conditions for surgeons, reduced intra-operative risks of perforation and organ damage, and improved patient comfort in the post-operative period.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- pneumoperitoneum pressure, curarization
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This is a non-interventional observational study. It will simply look at the data and compare them between the monitors provided.
| Study group | Role | What they receive |
|---|---|---|
| the group will be composed of patients undergoing laparoscopic surgery | the group will be made up of patients undergoing laparoscopic surgery and willing to take part in the pressure monitoring study. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
Evaluate the relationship between variation in intra-abdominal pressure and depth of curarization.
Measured: one day
Secondary outcomes (3)
secondary outcome
Study whether there is a link between variation in abdominal pressure level and postoperative pain.
Measured: 3 month
secondary outcome
To study whether taking insufflation pressure into account reduces the need for intraoperative curare administration.
Measured: one day
secondary outcome
To study whether taking into account variations in insufflation pressure can reduce the dose of curare administered.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005518
- Sponsor's protocol ID
- PneumandTOF
- Acronym
- PneumandTOF
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between Curarization and Pneumoperitoneum in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07005518
- Acronym / sponsor ID
- PneumandTOF / PneumandTOF
- Keywords
- pneumoperitoneum pressure, curarization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 5 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.
The number of surgical procedures is increasing worldwide (1). Laparoscopic surgery is one of the surgical techniques that has become indispensable. Laparoscopic surgery is less invasive than laparotomy. Laparoscopic surgery is performed in several stages, one of which involves the creation of a peritoneal detachment. This detachment is achieved by the addition of a gas (CO2), which requires total relaxation of the abdominal muscle fibers. To achieve this, it is advisable to administer a muscle relaxant called curare (2). Curare-induced neuromuscular block, its depth and its release must be monitored during surgery. Curares act as acetylcholine antagonists, inducing neuromuscular block by competing with this neurotransmitter. In France, only one type of device, called an accelerometer, is used to monitor curarization. This device couples electrical stimulation of a nerve with an accelerometer. Curarization can be said to be deep, moderate, residual or absent. Despite curarization appearing deep to the accelerometer, operating conditions do not always seem ideal for abdominal contraction. Indeed, the muscles tested with this device do not concern the muscles involved in laparoscopic surgery.
A currently unexploited surgical parameter, variation in insufflation pressure, could change our approach to intraoperative curarization.
Detailed description
Curarization is a fundamental part of surgical management. The administration of these drugs enables intubation and facilitates surgical work. However, these molecules need to be monitored at every stage, from anesthetic induction to patient awakening. Today, a single device is used in operating theatres to monitor the depth of patient curarization. This tool is used on a daily basis, and its use is strongly recommended by the various learned societies associated with anesthesia. Its use in operating theatres is compulsory by law. The device is used either on the ulnar nerve, generating a contraction of the adductor muscle of the thumb, or on the facial nerve, generating a contraction of the orbicularis muscle of the eye. This reflects the curarization of the laryngeal and diaphragmatic muscles. The device delivers repetitive electrical stimulation to these nerves, producing a muscle contraction. The number of muscle contractions in response to these stimulations, and the strength developed by the fourth response compared with the first, indicates the depth of curarization. These measurements are called a train of four.
While performing a train-of-four on the thumb adductor produces measured, quantifiable data, this is absolutely not the case for the orbicularis of the eye, which provides only crude, unreliable data intraoperatively.
Laparoscopic surgery, on the other hand, is a minimally invasive technique that has become increasingly popular in recent decades. It requires deep intraoperative curarization.
This surgical technique can be used for a wide range of urological, visceral and gynecological procedures.
During laparoscopic surgery, insufflation pressure is delivered via trocars into the patient's abdominal cavity. This pressure comes from a column supplied via a carbon dioxide (CO2) cylinder. Initially, a pressure is generated and adjusted at the surgeon's request (3). This pressure creates a space known as the pneumoperitoneum. In the event of insufficient pneumoperitoneum to enable surgery to be performed under optimum conditions, potentially due to a lack of deep curarization, the insufflation pressure is increased at the surgeon's request. This surgical technique is nonetheless prone to causing significant projected pain. As Madsen's study (4) suggests, lowering the insufflation pressure could therefore result in less pain.
By hypothesizing that imperfect curarization would lead to contraction of the abdominal muscles, generating intra-abdominal overpressure. This study investigates the role of intra-abdominal pressure variation in laparoscopic surgery and its correlation with the accelerometer used in current practice. If this hypothesis proves to be true, the expected benefits would be improved operating conditions for surgeons, reduced intra-operative risks of perforation and organ damage, and improved patient comfort in the post-operative period.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the group will be composed of patients undergoing laparoscopic surgery | – | Other: No Intervention: Observational Cohortthe group will be made up of patients undergoing laparoscopic surgery and willing to take part in the pressure monitoring study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-inclusion criteria: patients whose anesthetic maintenance is performed with Propofol IACP, patients who have undergone more than 3 intra-abdominal surgical procedures, patients with conversion to laparotomy.
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 |
|---|---|---|
| No Intervention: Observational CohortThis is a non-interventional observational study. It will simply look at the data and compare them between the monitors provided. | Other | the group will be composed of patients undergoing laparoscopic surgery |
Primary outcome
Primary outcome measure
Time frame: one day
Evaluate the relationship between variation in intra-abdominal pressure and depth of curarization.
3 secondary outcomes
secondary outcome
Time frame: 3 month
secondary outcome
Time frame: one day
secondary outcome
Time frame: one day
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 18 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Surgery and Neuromuscular Blocking Agents, run by Poitiers University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Guillaume BEAUMATIN, Phd student (+33 638267808, guillaume.beaumatin@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure (time frame: one day). 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 18 Jun 2025.