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The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04477694
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Yonca Özvardar Pekcan, Baskent University

Brief Summary:

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.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Sedoanalgesia Procedure: colonoscopy under sedoanalgesia

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Diabetes Mellitus on Hemodynamics, Procedure Times, Anesthetic Consumption and Complications in Colonoscopy Under Sedoanalgesia
Estimated Study Start Date : July 29, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
type II diabetic patients Procedure: colonoscopy under sedoanalgesia
Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.

non-diabetic patients Procedure: colonoscopy under sedoanalgesia
Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.




Primary Outcome Measures :
  1. Comparison of mean blood pressure in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia [ Time Frame: 24 hour ]
    After sedoanalgesia is applied mean blood pressure will be recorded.

  2. Comparison of heart rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia [ Time Frame: 24 hour ]
    After sedoanalgesia is applied heart rate will be recorded.

  3. Comparison of SpO2 in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia [ Time Frame: 24 hour ]
    After sedoanalgesia is applied SpO2 will be recorded.

  4. Comparison of respiratuar rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia [ Time Frame: 24 hour ]
    After sedoanalgesia is applied respiratuar rate will be recorded.

  5. Comparison of Ramsay sedation score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia [ Time Frame: 24 hour ]
    After sedoanalgesia is applied Ramsay sedation score level will be recorded. Ramsay sedation score level will be 3 during the process. When the score level is 2, at the end of the procedure, it will be taken to the postoperative intensive care unite.

  6. Comparison of Modified post anaesthetic discharge score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia [ Time Frame: 24 hour ]
    After sedoanalgesia is applied modified post anaesthetic discharge score level will be recorded. Patients will be discharged when the score level is 9 or above.

  7. Comparison of procedure times in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia [ Time Frame: 24 hour ]
    After sedoanalgesia is applied procedure times will be recorded.

  8. Comparison of total anaesthetic doses in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia [ Time Frame: 24 hour ]
    After sedoanalgesia is applied total anaesthetic doses will be recorded.

  9. Comparison of stomach ache and other effects in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia [ Time Frame: 24 hour ]
    After sedoanalgesia is applied stomach ache and other effects will be recorded. Stomach ache will be evaluated by visuel analog pain scale. When it is 4 or above, will be considered meaningful.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Type II diabetic and non-diabetic ASA I-II, aged between 18-65 years female patients scheduled for elective colonoscopy under sedoanalgesia
Criteria

Inclusion Criteria:

  • Female patients aged between 18-65 years old
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477694


Contacts
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Contact: Yonca Özvardar Pekcan +90 232 2411000 ext 1085 yncapek@gmail.com
Contact: Bahattin Tuncalı +90 232 2411000 ext 1260 tuncali.bahattin@gmail.com

Locations
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Turkey
Baskent University Zubeyde Hanim Practice and Research Center Recruiting
İzmir, Karşıyaka, Turkey, 35540
Contact: Özvardar Pekcan    +90 232 2411000 ext 1085    yncapek@gmail.com   
Contact: Tuncalı    +90 232 2411000 ext 1260    tuncali.bahattin@gmail.com   
Sponsors and Collaborators
Baskent University
Publications:
31. Kayhan Z: Ağrının ölçülmesi: Klinik Anestezi 2019; Logos yayıncılık
32. Satman İ, Alagöl F, Ömer B, Kalaca S, Tütüncü Y, Çolak N. Türkiye Diyabet, Hipertansiyon, Obezite ve Endokrinolojik Hastalıklar Prevalans Çalışması-II. (TURDEP II) 2011.

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Responsible Party: Yonca Özvardar Pekcan, MD, Anesthesia and Reanimation specialist, principal Investigator, Baskent University
ClinicalTrials.gov Identifier: NCT04477694    
Other Study ID Numbers: K19/320
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonca Özvardar Pekcan, Baskent University:
Diabetes mellitus
Sedoanalgesia
Colonoscopy under sedoanalgesia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases