Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
Study NCT ID:
NCT00372268
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2006-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: