Aeroneb® Pro (Nektar® Company)
DeviceThe Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.
NCT Number: NCT00372268
During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia. Different types of gas conditioning have been studied in order to prevent this specific hypothermia. Intra-abdominal administration of local anesthetics has also been studied in order to prevent post-operative pain. In both cases, some results have been described.
The investigators propose to evaluate in a prospective, randomized, double blind trial, the impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning are:
* CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl * CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal administration of Nacl * CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2% * CO2 dry and cold with direct intra-abdominal administration of Nacl
The investigators use a new device (Aeroneb® Pro [Aerogen® Company]) which can wet (by nebulization) the insufflated gas and therefore permits intraperitoneal medicament administration (local anesthetics).
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Sihcus-Cmco, Schiltigheim, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.
Time frame: From the beginning of the anesthetic procedure to the discharge of the recovery room.
Time frame: From the arrival in the recovery room to the 6th post-operative day.
Time frame: From the beginning of the anesthetic procedure to the end of the surgical procedure (one blood sample is done before the surgery, the second is done just after the arrival in the recovery room)
Time frame: From the discharge of the recovery room to the 6th post-operative day
Time frame: During the duration of the surgical procedure.
University Hospital, Strasbourg, France
Other
Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01393925
Anti-Inflammatory Agents, Non-Steroidal, Laparoscopy
Guangzhou, Guangdong, China
View Trial DetailsNCT06734494
Acute Appendicitis, Appendicitis
Clermont-Ferrand, Auvergne, France
View Trial DetailsNCT05572775
Anesthesia Regional, Chronic Post Operative Pain
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
View Trial DetailsNCT03420586
Anesthesia Recovery Period, Anesthesia, General
Zadar, Croatia
View Trial Details