CO2 Absorption During Laparoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01340989
Recruitment Status : Completed
First Posted : April 25, 2011
Last Update Posted : October 26, 2011
Information provided by (Responsible Party):
Jasper Verguts, University Hospital, Gasthuisberg

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.

Condition or disease Intervention/treatment Phase
Pneumoperitoneum Procedure: alteration of the insufflation gas Procedure: full conditioning Procedure: standard pneumoperitoneum Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation of Adding 4% of Oxygen and 10% of Nitrous Oxide to the CO2 Pneumoperitoneum Upon CO2 Resorption.
Study Start Date : August 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 4% oxygen
addition of 4% oxygen to the CO2 pneumoperitoneum
Procedure: alteration of the insufflation gas
addition of 4% oxygen
Experimental: full conditioning
full conditioning of the peritoneal cavity by the laparoscopic gas: 4% oxygen, 10% nitrous oxide, humidification and set temperature of 32°C
Procedure: full conditioning

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

  • humidification
  • set temperature of 32°C
Active Comparator: CO2 pneumoperitoneum
standard laparoscopy with CO2 pneumoperitoneum
Procedure: standard pneumoperitoneum
no intervention besides the use of CO2

Primary Outcome Measures :
  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 Outcome Measures :
  1. hemodynamic alterations [ Time Frame: measurements for 60 to 240 minutes on average during surgery ]
    control of other hemodynamic alterions during laparoscopic surgery.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts 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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01340989

UZ Leuven, campus Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg

Responsible Party: Jasper Verguts, MD, University Hospital, Gasthuisberg Identifier: NCT01340989     History of Changes
Other Study ID Numbers: s52645
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011

Keywords provided by Jasper Verguts, University Hospital, Gasthuisberg:
women undergoing laparoscopic surgery for: hysterectomy, colpopexy, endometriosis, adhesions or myomas

Additional relevant MeSH terms:
Peritoneal Diseases
Digestive System Diseases
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents