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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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RPCEC |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
RPCEC00000186 |
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Date of registration:
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09/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Insufflation with CO2 versus room air in colonoscopy
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Scientific title:
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Carbon dioxide insufflation colonoscopy. Randomized controlled trial and double blind. - ICOC |
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Date of first enrolment:
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13/10/2014 |
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Target sample size:
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100 |
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Recruitment status: |
Complete |
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URL:
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https://rpcec.sld.cu/en/trials/RPCEC00000186-En |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Other
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Phase:
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2
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Osvaldo Raiko
Seijas Cabrera |
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Address:
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Parraga Street e/ San Mariano y Vista Alegre. La Vibora. 10 de Octubre.
10700
Havana
Cuba |
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Telephone:
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seijascabrera@infomed.sld.cu |
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Email:
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Affiliation:
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National Centre for Minimal Access Surgery ( CNCMA) |
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Name:
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Osvaldo Raiko
Seijas Cabrera |
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Address:
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Parraga Street e/ San Mariano y Vista Alegre. La Vibora. 10 de Octubre.
10700
Havana
Cuba |
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Telephone:
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Email:
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seijascabrera@infomed.sld.cu |
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Affiliation:
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National Centre for Minimal Access Surgery (CNCMA) |
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Key inclusion & exclusion criteria
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Inclusion criteria: Male and female patients with 18 or more years old
Exclusion criteria: 1. Severe respiratory illness (hospitalization in the last 6 months or home oxygen therapy),
2. Sleep Apnea.
3. Morbid obesity. (BMI = 35)
4. Inability to understand the study.
5. Performing on the day of upper endoscopy and colonoscopy.
6. Making sigmoidoscopy
7. Patients who refuse consent for participation in the study.
Age minimum:
18 years
Age maximum:
None
Gender:
Male/Female
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Health Condition(s) or Problem(s) studied
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Patients indicated for Colonoscopy
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Intervention(s)
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Expermiental Group (CO2): Colonoscopy is performed by blowing CO 2
Control Group (Placebo): Colonoscopy is performed by blowing ambient air.
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Primary Outcome(s)
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Pain (Visual Analogue Scale). Measuring time: 15 minutes, 1 hour after procedure.
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Secondary Outcome(s)
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Number of Propofol ( Total amount of anesthetic was required) Measuring time: After procedure.
Total Time (Time elapsed since the start of colonoscopy until completion the procedure) Measuring time: After procedure.
CO2 pressure ( Value of measuring CO2 in the patient ) Measuring time: before, during and after procedure.
O2 Saturation( Value of measuring O2 presented by the patient) Measuring time: before, during and after procedure.
Heart rate (number of heartbeats in the patient) Measuring time: before, during and pafter procedure.
Complications (Presence of complications due to come) Measuring time: during and after procedure.
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Source(s) of Monetary Support
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Cuban Ministry of Public Health (MINSAP)
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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