NCT01340989

CO2 Absorption During Laparoscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Gasthuisberg · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Pneumoperitoneum

Interventions

Type	Name	Description
PROCEDURE	alteration of the insufflation gas	addition of 4% oxygen
PROCEDURE	full conditioning	addition of 4% oxygen + 10% nitrous oxide to the peritoneum * humidification * set temperature of 32°C
PROCEDURE	standard pneumoperitoneum	no intervention besides the use of CO2

Timeline

• Start date: 2006-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-04-25
• Last updated: 2011-10-26

Locations

1 site across 1 country: Belgium