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CO2 Absorption During Laparoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jasper Verguts, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01340989
First received: April 21, 2011
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Pneumoperitoneum
 Procedure: alteration of the insufflation gas
Procedure: full conditioning
Procedure: standard pneumoperitoneum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Evaluation of Adding 4% of Oxygen and 10% of Nitrous Oxide to the CO2 Pneumoperitoneum Upon CO2 Resorption.

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • CO2 absorption [ Time Frame: measurements for 60 to 240 minutes on average during surgery ] [ Designated as safety issue: Yes ]
    Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia)


Secondary Outcome Measures:
  • hemodynamic alterations [ Time Frame: measurements for 60 to 240 minutes on average during surgery ] [ Designated as safety issue: Yes ]
    control of other hemodynamic alterions during laparoscopic surgery.


Estimated Enrollment: 60
Study Start Date: August 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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…)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340989

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

No publications provided

Responsible Party: Jasper Verguts, MD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01340989     History of Changes
Other Study ID Numbers: s52645
Study First Received: April 21, 2011
Last Updated: October 25, 2011
Health Authority: Belgium: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013