CO2 Absorption During Laparoscopy

Pneumoperitoneum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340989
• Other study ID #: s52645
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: October 25, 2011
• Start date: August 2006
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women/men planned to undergo a laparoscopic intervention for at least 1 hour and having signed the informed consent

Exclusion Criteria:

• Pregnancy

• Immunodeficiency

• Refuse or unable to sign informed consent

• Chronic disease (i.e. COPD, Crohn, cardiac…)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumoperitoneum

Intervention

Procedure:
• alteration of the insufflation gas
addition of 4% oxygen
• full conditioning
addition of 4% oxygen + 10% nitrous oxide to the peritoneum humidification set temperature of 32°C
• standard pneumoperitoneum
no intervention besides the use of CO2

Locations

Country	Name	City	State
Belgium	UZ Leuven, campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CO2 absorption	Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia)	measurements for 60 to 240 minutes on average during surgery	Yes
Secondary	hemodynamic alterations	control of other hemodynamic alterions during laparoscopic surgery.	measurements for 60 to 240 minutes on average during surgery	Yes