The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effect of Diabetes Mellitus on Hemodynamics, Procedure Times, Anesthetic Consumption and Complications in Colonoscopy Under Sedoanalgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04477694
• Other study ID #: K19/320
• Status: Recruiting
• Start date: December 27, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• Source: Baskent University
• Contact: Yonca Özvardar Pekcan
• Phone: +90 232 2411000
• Email: yncapek[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Sedoanalgesia

Intervention

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

Locations

Country	Name	City	State
Turkey	Baskent University Zubeyde Hanim Practice and Research Center	Izmir	Karsiyaka

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of mean blood pressure in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia	After sedoanalgesia is applied mean blood pressure will be recorded.	24 hour
Primary	Comparison of heart rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia	After sedoanalgesia is applied heart rate will be recorded.	24 hour
Primary	Comparison of SpO2 in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia	After sedoanalgesia is applied SpO2 will be recorded.	24 hour
Primary	Comparison of respiratuar rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia	After sedoanalgesia is applied respiratuar rate will be recorded.	24 hour
Primary	Comparison of Ramsay sedation score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia	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.	24 hour
Primary	Comparison of Modified post anaesthetic discharge score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia	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.	24 hour
Primary	Comparison of procedure times in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia	After sedoanalgesia is applied procedure times will be recorded.	24 hour
Primary	Comparison of total anaesthetic doses in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia	After sedoanalgesia is applied total anaesthetic doses will be recorded.	24 hour
Primary	Comparison of stomach ache and other effects in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia	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.	24 hour