The Effect of Diabetes Mellitus in Colonoscopy Under Sedoanalgesia

March 9, 2023 updated by: Yonca Özvardar Pekcan, Baskent University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yonca Özvardar Pekcan
  • Phone Number: 1085 +90 232 2411000
  • Email: yncapek@gmail.com

Study Contact Backup

Study Locations

  • Turkey
    • Karşıyaka
      • İzmir, Karşıyaka, Turkey, 35540
        • Recruiting
        • Baskent University Zubeyde Hanim Practice and Research Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hour
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.
24 hour
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.
24 hour
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.
24 hour
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.
24 hour
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.
24 hour
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.
24 hour
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.
24 hour
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.
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2020

Primary Completion (Actual)

November 30, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K19/320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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