Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372268
Status:
COMPLETED
Last Update Posted:
2012-04-13
First Post:
2006-09-05
Brief Title:
Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
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:
2012-04
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 075 and direct intra-abdominal administration of Nacl
CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 02
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 075 and direct intra-abdominal administration of Nacl
CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 02
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:
None
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?:
None