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

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.

Study Overview

• Status: Completed
• Conditions: Outpatients
• Intervention / Treatment: Procedure: Insufflation with CO2

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Division of Gastroenterology, Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Insertion without CO2 insufflation; Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.	Procedure: Insufflation with CO2; Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.; Other Names: the Olympus UCR Endoscopic CO2 Regulation Unit
EXPERIMENTAL: Insertion with CO2; Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.	Procedure: Insufflation with CO2; Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.; Other Names: the Olympus UCR Endoscopic CO2 Regulation Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
delayed bleeding	One day
colonoscopic cecal intubation time	One day
completeness of intubation	One day
loop formation	One day

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Study Chair: Tsai-Yuan Hsieh, MD.PhD, Division of Gastroenterology, Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (ESTIMATE): August 11, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 3, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: TSGH-C99-062