Clinical Trial: CO2 Absorption During Laparoscopy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Adding 4% of Oxygen and 10% of Nitrous Oxide to the CO2 Pneumoperitoneum Upon CO2 Resorption.

Brief Summary: CO2 absorption from the pneumoperitoneum increases over time during laparoscopic procedures. Adding 4% of oxygen to the carbon dioxide was shown in rabbits to decrease CO2 resorbtion through prevention of mesothelial hypoxia. We want to prove this concept in human and expand it to the use of full conditioning.

Detailed Summary: In order to confirm the animal data in the human, a first RCT was performed in which 20 women undergoing a laparoscopy for at least 60 minutes were randomised to a pneumoperitoneum with either 100% carbon dioxide or 96% carbon dioxide plus 4% of oxygen. Insufflation pressure and Trendelenburg were standardised at 15 mm Hg and 30° respectively. In a second trial women were randomized to either 100% carbon dioxide or 86% carbon dioxide plus 4% of oxygen + 10% nitrous oxide + humidification and set temperature of 32°C of the peritoneal cavity.
Sponsor: University Hospital, Gasthuisberg

Current Primary Outcome: CO2 absorption [ Time Frame: measurements for 60 to 240 minutes on average during surgery ]

Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia)


Original Primary Outcome: Same as current

Current Secondary Outcome: hemodynamic alterations [ Time Frame: measurements for 60 to 240 minutes on average during surgery ]

control of other hemodynamic alterions during laparoscopic surgery.


Original Secondary Outcome: Same as current

Information By: University Hospital, Gasthuisberg

Dates:
Date Received: April 21, 2011
Date Started: August 2006
Date Completion:
Last Updated: October 25, 2011
Last Verified: October 2011