The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients

Outpatients Clinical Trial

Official title:

The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415076
• Other study ID #: TSGH-C99-062
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: September 3, 2012
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted through the lungs. This reduces the effects of colonic distension and minimizes intracolonic gas at the end of the examination. The aims of the study were to evaluate the timing of administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients with an appropriate indication for colonoscopy were considered eligible.

Exclusion Criteria:

• Exclusion criteria included severe hematochezia, acute colonic pseudo-obstruction, known obstructive lesions, age <18 years, prior colon resection, fulminant colitis, chronic obstructive pulmonary disease requiring oxygen, and a medical history of CO2 retention. Patients that required only a partial colonoscopy or were unable to read or understand Chinese were also excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Outpatients

Intervention

Procedure:
• Insufflation with CO2
Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.

Locations

Country	Name	City	State
Taiwan	Division of Gastroenterology, Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abdominal pain during and after colonoscopy	Pain was recorded on a ten-point visual analog scale (0- no pain, 10- worst imaginable pain) at left-sided colonoscopic insertion, right-sided colonoscopic insertion, and at 1, 3, 6, and 24 hours postprocedure.	One day	No
Secondary	delayed bleeding		One day	No
Secondary	colonoscopic cecal intubation time		One day	No
Secondary	completeness of intubation		One day	No
Secondary	loop formation		One day	No