Clinical trial NCT04477694: The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia
Official title: The Effect of Diabetes Mellitus on Hemodynamics, Procedure Times, Anesthetic Consumption and Complications in Colonoscopy Under Sedoanalgesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Sedoanalgesia
Keywords: Diabetes mellitus
Sedoanalgesia
Colonoscopy under sedoanalgesia
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Comparison of mean blood pressure in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
timeFrame: 24 hour
measure: Comparison of heart rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
timeFrame: 24 hour
measure: Comparison of SpO2 in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
timeFrame: 24 hour
measure: Comparison of respiratuar rate in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
timeFrame: 24 hour
measure: Comparison of Ramsay sedation score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
timeFrame: 24 hour
measure: Comparison of Modified post anaesthetic discharge score level in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
timeFrame: 24 hour
measure: Comparison of procedure times in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
timeFrame: 24 hour
measure: Comparison of total anaesthetic doses in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
timeFrame: 24 hour
measure: Comparison of stomach ache and other effects in diabetic and non-diabetic patients in colonoscopy under sedoanalgesia
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Baskent University Zubeyde Hanim Practice and Research Center
state: Karşıyaka
Study officials:
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