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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastrointestinal Dysfunction, Alteration of Cognitive Function

Intervention / Treatment
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* Drug: Midazolam
* Drug: Meperidine
* Drug: Remifentanil
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group MM<br>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<br>* Dosage adjustment<br>* Other names: Versed;Drug: Meperidine<br>* Dosage adjustment<br>* Other names: Demerol;|
| Other: Group RP<br>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<br>* Dosage adjustment<br>* Other names: Ultiva;Drug: Propofol<br>* Dosage adjustment<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Function | 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 | 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 | 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 | Heart rate as measured in beats per minute | Baseline and 1,2,3,5,10,15 and 20 minutes | 
| Mean Arterial Pressure | mean arterial blood pressure as measured in mmHg | Baseline and 1,2,3,5,10,15 and 20 minutes | 
| Peripheral Oxygen Saturation | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive dysfunction, Colonoscopy, Sedation