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OpenTrials
Completed

NCT Number: NCT01340989

CO2 Absorption During Laparoscopy

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.

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Key information

Conditions

Pneumoperitoneum Cicatrix Digestive System Diseases Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Genital Diseases Genital Diseases, Female Myoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Tissue Adhesions Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

alteration of the insufflation gas

Procedure

addition of 4% oxygen

full conditioning

Procedure

addition of 4% oxygen + 10% nitrous oxide to the peritoneum

  • humidification
  • set temperature of 32°C

standard pneumoperitoneum

Procedure

no intervention besides the use of CO2

Primary outcomes

  1. 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)

Secondary outcomes

  1. hemodynamic alterations

    Time frame: measurements for 60 to 240 minutes on average during surgery

    control of other hemodynamic alterions during laparoscopic surgery.

Sponsors and collaborators

Lead sponsor

University Hospital, Gasthuisberg

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Apr 25, 2011
Registry last updated
Oct 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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