CO2 Absorption During Laparoscopy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01340989

Enrollment

Registered

2011-04-25

Start date

2006-08-31

Completion date

2011-09-30

Last updated

2011-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumoperitoneum

Keywords

women undergoing laparoscopic surgery for: hysterectomy, colpopexy, endometriosis, adhesions or myomas

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 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.

Interventions

PROCEDUREalteration of the insufflation gas

addition of 4% oxygen

PROCEDUREfull conditioning

addition of 4% oxygen + 10% nitrous oxide to the peritoneum * humidification * set temperature of 32°C

PROCEDUREstandard pneumoperitoneum

no intervention besides the use of CO2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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…)

Design outcomes

Primary

Measure	Time frame	Description
CO2 absorption	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)

Secondary

Measure	Time frame	Description
hemodynamic alterations	measurements for 60 to 240 minutes on average during surgery	control of other hemodynamic alterions during laparoscopic surgery.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026