The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia

Baskent University

Status: Enrolling

Conditions: Sedoanalgesia; Diabetes Mellitus, Type 2

Treatments: Procedure: colonoscopy under sedoanalgesia

Study type: Observational

Funder types: Other

Identifiers

NCT04477694

K19/320

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

type II diabetic patients

Treatment:

Procedure: colonoscopy under sedoanalgesia

non-diabetic patients

Treatment:

Procedure: colonoscopy under sedoanalgesia