Study of the Relationship Between Curarization and Pneumoperitoneum in Laparoscopic Surgery

NCT07005518 | Not Yet Recruiting

• 1 other identifier: PneumandTOF
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Laparoscopic Surgery; Neuromuscular Blocking Agents; Pneumoperitoneum

Keywords

pneumoperitoneum pressure; curarization

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure

  Evaluate the relationship between variation in intra-abdominal pressure and depth of curarization.

  one day

Secondary Outcomes (3)

• secondary outcome

  3 month

• secondary outcome

  one day

• secondary outcome

  one day

Study Arms (1)

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.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

This is a non-interventional observational study. It will simply look at the data and compare them between the monitors provided.

the group will be composed of patients undergoing laparoscopic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Poitiers University Hospital: lead

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Central Study Contacts

Guillaume BEAUMATIN, Phd student

CONTACT

+33 638267808; guillaume.beaumatin@chu-poitiers.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06