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The Use of CO2 in Routine-Colonoscopy

Is CO2 Insufflation an Amelioration of Routine Colonoscopy?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03141697
Enrollment
150
Registered
2017-05-05
Start date
2012-04-01
Completion date
2014-08-31
Last updated
2017-05-05

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

Conditions

Colonoscopy

Keywords

Carbon Dioxide, Coloboscopy

Brief summary

In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy were assigned to either CO2 or air insufflation. We recorded basic characteristics of colonoscopy and the amount of drugs used for sedation. Patients and investigators filled out questionnaires to record pain, abdominal bloating and flatulence.

Detailed description

Between April 2012 and August 2014 150 patients referred to the University Hospital of Leipzig for colonoscopy were randomly assigned to either CO2 or air insufflation. All examinations were performed by one of four experienced endoscopists. The patients usually received sedation. For sedation midazolam and propofol was used. At the beginning of the examination the patients usually received between 3-5 mg of midazolam and 20-40 mg propofol. During endoscopy propofol was titrated by administration of 20 mg at the time according to and pain reaction of the patient and required depth of sedation. All patients had nasal insufflation of oxygen with 2 litres per minute. All sedated patients were monitored for pulse, blood pressure and blood oxygen saturation. For bowel cleansing a solution of Macrogol 3350 (Moviprep®, Norgine) was administered orally according to the manufacturer. All colonoscopies were performed using Fujifilm Endoscopes (EC 590 Series). For examinations with use of carbon dioxide the Fujifilm CO2 Insufflator GW-1 was used with appropriate water bottle and endoscope valve. The air pump of the light source Fujifilm System 4400 was deactivated according to the manufacturer.

Interventions

DEVICERoom air

Insufflation of room air

DEVICECarbon Dioxide

Insufflation of Carbon Dioxide

Sponsors

University of Leipzig
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* older than 18 years * informed consent

Exclusion criteria

* former colonic resections * severe heart or lung disease (NYHA III or IV) * Pregnancy * Patients with planned gastroscopy within 24 hours

Design outcomes

Primary

MeasureTime frameDescription
Post-procedural pain0 - 24 hrs after colonoscopyPain after Colonoscopy, assessed by visual analog scale (VAS)

Secondary

MeasureTime frameDescription
Abdominal bloating0 - 24 hrs after colonoscopyAbdominal bloating, assessed by questionaire
flatulence0 - 24 hrs after colonoscopyflatulence, assessed by questionaire
procedure timeduration of colonoscopytime used for colonoscopy
Used amount of sedative drugsduring endoscopyAmount of midazolam and propofol administrated during colonoscopy

Countries

Germany

Outcome results

None listed

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