The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia
NCT ID: NCT04477694
Last Updated: 2023-03-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
100 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-12-27
Study Completion Date
2023-06-30
Brief Summary
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INTRODUCTION AND AIM Diabetes Mellitus (DM) is a common endocrine disease in the world. Colon polyps and colorectal cancers are reported more in DM patients. Therefore diabetic patients are recommended to have colonoscopy frequently. The aim of this study is to search the effect of DM on hemodynamics, procedure times, anesthetic consumption and complications in colonoscopy under sedoanalgesia.
MATERIALS AND METHODS Following Institutional Review Board and Ethics Committee approval of Başkent University, this study is planned to be prospective and double-blind in 50 type II diabetic and 50 non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for elective colonoscopy under sedoanalgesia. Exclusion criteria are age outside the range of 18-65 years, ASA phsical status ≥ 3, inability to provide informed consent, pregnancy, previous adverse reactions to medications used in the study, history of anesthesia and sedation in the last 7 days, psychiatric or emotional disorders, addiction to the opioids or sedatives used in the study, diabetic nephrophathy, high BUN and creatinine values, advanced stages of diabetic nonalcoholic liver disease and high liver function tests, diabetic sensorymotor and autonomic neuropathy.
After sedoanalgesia is applied systolic and diastolic blood pressure, heart rate, SpO2, respiratory rate, RSS, MPADS, procedure times, total anesthetic doses, stomach ache and other effects will be recorded.
EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS There is evidence about determining the risks that diabetic patients have during colonoscopy and applying a special patient care protocol for these patients is suggested to improve the procedure and outcomes.
MATERIALS AND METHODS Following Institutional Review Board and Ethics Committee approval of Başkent University, this study is planned to be prospective and double-blind in 50 type II diabetic and 50 non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for elective colonoscopy under sedoanalgesia. Exclusion criteria are age outside the range of 18-65 years, ASA phsical status ≥ 3, inability to provide informed consent, pregnancy, previous adverse reactions to medications used in the study, history of anesthesia and sedation in the last 7 days, psychiatric or emotional disorders, addiction to the opioids or sedatives used in the study, diabetic nephrophathy, high BUN and creatinine values, advanced stages of diabetic nonalcoholic liver disease and high liver function tests, diabetic sensorymotor and autonomic neuropathy.
After sedoanalgesia is applied systolic and diastolic blood pressure, heart rate, SpO2, respiratory rate, RSS, MPADS, procedure times, total anesthetic doses, stomach ache and other effects will be recorded.
EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS There is evidence about determining the risks that diabetic patients have during colonoscopy and applying a special patient care protocol for these patients is suggested to improve the procedure and outcomes.
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Detailed Description
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Conditions
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Diabetes Mellitus, Type 2
Sedoanalgesia
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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type II diabetic patients
colonoscopy under sedoanalgesia
Intervention Type
PROCEDURE
Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.
non-diabetic patients
colonoscopy under sedoanalgesia
Intervention Type
PROCEDURE
Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.
Interventions
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colonoscopy under sedoanalgesia
Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Female patients aged between 18-65 years old
* Type II diabetic and non-diabetic
* Type II diabetic and non-diabetic
Exclusion Criteria
* Age outside the range of 18-65 years
* ASA phsical status ≥ 3
* Inability to provide informed consent
* Pregnancy
* Previous adverse reactions to medications used in the study
* History of anesthesia and sedation in the last 7 days
* Psychiatric or emotional disorders
* Addiction to the opioids or sedatives used in the study
* Diabetic nephrophathy, high BUN and creatinine values
* Advanced stages of diabetic nonalcoholic liver disease and high liver function tests
* Diabetic sensorymotor and autonomic neuropathy
* ASA phsical status ≥ 3
* Inability to provide informed consent
* Pregnancy
* Previous adverse reactions to medications used in the study
* History of anesthesia and sedation in the last 7 days
* Psychiatric or emotional disorders
* Addiction to the opioids or sedatives used in the study
* Diabetic nephrophathy, high BUN and creatinine values
* Advanced stages of diabetic nonalcoholic liver disease and high liver function tests
* Diabetic sensorymotor and autonomic neuropathy
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Baskent University
OTHER
Sponsor Role
lead
Responsible Party
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Yonca Özvardar Pekcan
MD, Anesthesia and Reanimation specialist, principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Baskent University Zubeyde Hanim Practice and Research Center
Izmir, Karşıyaka, Turkey (Türkiye)
Site Status
RECRUITING
Countries
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Turkey (Türkiye)
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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K19/320
Identifier Type: -
Identifier Source: org_study_id
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