The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia

NCT04477694 | Unknown

• 1 other identifier: K19/320
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Sedoanalgesia

Keywords

Diabetes mellitus; Sedoanalgesia; Colonoscopy under sedoanalgesia

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• Comparison of SpO2 in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia

  After sedoanalgesia is applied SpO2 will be recorded.

  24 hour

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

type II diabetic patients

Procedure: colonoscopy under sedoanalgesia

non-diabetic patients

Procedure: colonoscopy under sedoanalgesia

Interventions

colonoscopy under sedoanalgesia PROCEDURE

Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.

non-diabetic patients; type II diabetic patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Female patients aged between 18-65 years old
• Type II diabetic and non-diabetic

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Zubeyde Hanim Practice and Research Center

Izmir, Karşıyaka, 35540, Turkey (Türkiye)

RECRUITING

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Yonca Özvardar Pekcan

CONTACT

+90 232 2411000; yncapek@gmail.com

Bahattin Tuncalı

CONTACT

+90 232 2411000; tuncali.bahattin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesia and Reanimation specialist, principal Investigator

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 20, 2020
• Study Start: December 27, 2020
• Primary Completion: November 30, 2022
• Study Completion: June 30, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)