The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy

August 18, 2020 updated by: Perihan Ekmekçi, Ufuk University

The Effect of Different Sedation Regimes Administered by Anesthesiologists or Endoscopists on Cognitive Functions in Lower Gastrointestinal System Endoscopy

There are different sedation regimes for lower gastrointestinal system endoscopy which can be administered by anesthesiologists and non-anesthesiologists. This study aims to compare the effects of propofol/remifentanil combination and midazolam/meperidine combination on early cognitive function following lower gastrointestinal system endoscopies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sedation for lower gastrointestinal system endoscopies can be administered by anesthesiologists or endoscopists and cognitive dysfunction after this procedure has not been fully investigated. The aim of this study was to investigate the effect of different sedation regimes applied by anesthesiologists or endoscopists on early cognitive dysfunction. Following ethics committee approval and written informed consent, 100 patients were randomly divided into two groups. In Group MM where drug regime was solely determined by endoscopists, 2 mg midazolam and 20mg meperidine was given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) was given when facial pain scale (FPS) was greater than 3. In Group RP where drug regime was solely determined by anesthesiologists, 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus was administered and additional 0,5 mcg/kg remifentanil bolus was given when FPS was greater than 3. Bispectral index (BIS) and hemodynamic monitorization was carried out throughout the procedure and BIS 60-80 with FPS<3 was targeted. The time to Observer Assessment of Alertness/Sedation Scale (OAAS) score to reach 3 was measured after the procedure and Trieger Dot Test (TDT) and Digit Symbol Substitution Test (DSST) was repeated at 5th, 15th and 30th minutes.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 4

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 18-65 years of age (ASA I-III risk groups), scheduled for elective colonoscopy

Exclusion Criteria:

  • Patient refusal
  • Mini mental test (MMT) score<26
  • Amsterdam Preoperative Anxiety and Information Scale (APAIS ) score >10
  • Advanced cardiopulmonary or psychiatric disease
  • Chronic alcohol abuse
  • Morbid obesity
  • Known allergy to study drugs

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group MM
2 mg midazolam and 20mg meperidine given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) given when FPS greater than 3
Drug: Midazolam
Dosage adjustment
Other Names:
  • Versed
Drug: Meperidine
Dosage adjustment
Other Names:
  • Demerol
Other: Group RP
100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus administered and additional 0,5 mcg/kg remifentanil bolus given when FPS greater than 3
Drug: Remifentanil
Dosage adjustment
Other Names:
  • Ultiva
Drug: Propofol
Dosage adjustment
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive Function
Time Frame: Baseline and 5, 15, 30 minutes after the procedure
As measured by Trieger Dot Test. The test does not have an upper limit; the time taken to complete the test is added to the number of dots missed by the patient and a result is obtained. The lowest score possible is 0. Higher values represent worse outcomes.
Baseline and 5, 15, 30 minutes after the procedure
Change in Cognitive Function
Time Frame: Baseline and 5, 15, 30 minutes after the procedure
As measured by Digit Symbol Substitution Test. Scale range 0-9. No cut-off value. Higher results represent better outcomes
Baseline and 5, 15, 30 minutes after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale Scores From the Baseline
Time Frame: Baseline and 5, 15, 30 minutes after the procedure
Pain as measured by Visual Analogue Scale. Range 1-10. No cut-off value, Higher results represent worse outcomes
Baseline and 5, 15, 30 minutes after the procedure
Heart Rate
Time Frame: Baseline and 1,2,3,5,10,15 and 20 minutes
Heart rate as measured in beats per minute
Baseline and 1,2,3,5,10,15 and 20 minutes
Mean Arterial Pressure
Time Frame: Baseline and 1,2,3,5,10,15 and 20 minutes
mean arterial blood pressure as measured in mmHg
Baseline and 1,2,3,5,10,15 and 20 minutes
Peripheral Oxygen Saturation
Time Frame: Baseline and 1,2,3,5,10,15 and 20 minutes
peripheral oxygen saturation as measured by pulse oximeter. Units are percentages, Scale range 0-100.
Baseline and 1,2,3,5,10,15 and 20 minutes

Collaborators and Investigators

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

Sponsor

Ufuk University

Investigators

  • Principal Investigator: Perihan Ekmekçi, Assoc Prof, UFUK UNIVERSITY FACULTY OF MEDICINE

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

May 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UfukU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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