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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group MM | Other | 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 |
|
| Group RP | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Dosage adjustment |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perihan Ekmekçi, Assoc Prof | Ufuk University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14595310 | Result | Cohen LB, Dubovsky AN, Aisenberg J, Miller KM. Propofol for endoscopic sedation: A protocol for safe and effective administration by the gastroenterologist. Gastrointest Endosc. 2003 Nov;58(5):725-32. doi: 10.1016/s0016-5107(03)02010-8. | |
| 25685266 | Result | Ferreira AO, Cravo M. Sedation in gastrointestinal endoscopy: Where are we at in 2014? World J Gastrointest Endosc. 2015 Feb 16;7(2):102-9. doi: 10.4253/wjge.v7.i2.102. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 facial pain scale (FPS) greater than 3 Midazolam: Dosage adjustment Meperidine: Dosage adjustment |
| FG001 | 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 Remifentanil: Dosage adjustment Propofol: Dosage adjustment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Midazolam: Dosage adjustment Meperidine: Dosage adjustment |
| BG001 | Group RP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 5, 15, 30 minutes after the procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Midazolam: Dosage adjustment Meperidine: Dosage adjustment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Perihan Ekmekçi | Ufuk University Faculty of Medicine | +903122044000 | erdogduperi@gmail.com |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D008614 | Meperidine |
| D000077208 | Remifentanil |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Meperidine |
| Drug |
Dosage adjustment |
|
|
| Remifentanil | Drug | Dosage adjustment |
|
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| Propofol | Drug | Dosage adjustment |
|
|
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 |
| 19617584 | Result | Padmanabhan U, Leslie K, Eer AS, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg. 2009 Nov;109(5):1448-55. doi: 10.1213/ane.0b013e3181a6ad31. Epub 2009 Jul 17. |
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 Remifentanil: Dosage adjustment Propofol: Dosage adjustment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Mini Mental Test | A test consisting of 11 questions, range is 0 (worst)-30 (best). A score of 23 and lower is considered as cognitive impairment | Mean | Standard Deviation | units on a scale |
|
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
Remifentanil: Dosage adjustment
Propofol: Dosage adjustment
|
|
|
| Primary | Change in Cognitive Function | As measured by Digit Symbol Substitution Test. Scale range 0-9. No cut-off value. Higher results represent better outcomes | Posted | Mean | Standard Deviation | units on a scale | Baseline and 5, 15, 30 minutes after the procedure |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline and 5, 15, 30 minutes after the procedure |
|
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|
|
| Secondary | Heart Rate | Heart rate as measured in beats per minute | Posted | Mean | Standard Deviation | beats per minute | Baseline and 1,2,3,5,10,15 and 20 minutes |
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|
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| Secondary | Mean Arterial Pressure | mean arterial blood pressure as measured in mmHg | Posted | Mean | Standard Deviation | mmHg | Baseline and 1,2,3,5,10,15 and 20 minutes |
|
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|
|
| Secondary | Peripheral Oxygen Saturation | peripheral oxygen saturation as measured by pulse oximeter. Units are percentages, Scale range 0-100. | Posted | Mean | Standard Deviation | Percent of oxygenated hemoglobin | Baseline and 1,2,3,5,10,15 and 20 minutes |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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 Remifentanil: Dosage adjustment Propofol: Dosage adjustment | 0 | 50 | 0 | 50 |
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| D006571 | Heterocyclic Compounds |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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