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The purpose of this randomized double-blind trial is to define the correct dosage of Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and side effects.
90 patients undergoing colonoscopy will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil RS1 | Experimental |
| |
| Remifentanil RS2 | Experimental |
| |
| Meperidine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Patient receive a bolus of Remifentanil (0,5 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,5 mcg/Kg every time the patient presses its button. |
| Measure | Description | Time Frame |
|---|---|---|
| Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 | Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18. | > 0 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Satisfaction | The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction. | After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | 20132 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remifentanil RS1 | |
| FG001 | Remifentanil RS2 | |
| FG002 | Meperidine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remifentanil RS1 | |
| BG001 | Remifentanil RS2 | |
| BG002 | Meperidine |
| 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 | Discharge Time, the Time to Reach a Modified Aldrete Score ≥18 | Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18. | Posted | Median | Inter-Quartile Range | minutes | > 0 minutes |
|
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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 | Remifentanil RS1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Massimo Agostoni | Department of Anesthesia and Intensive Care | +39.02.2643.2656 | agostoni.massimo@hsr.it |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D008614 | Meperidine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Remifentanil | Drug | Patient receive a bolus of Remifentanil (0,8 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,8 mcg/Kg every time the patient presses its button. |
|
| Meperidine | Drug | Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected. |
|
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patient's Satisfaction | The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction. | Posted | Mean | Standard Deviation | units on a scale | After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone |
|
|
|
| 0 |
| 30 |
| 7 |
| 30 |
| EG001 | Remifentanil RS2 | 0 | 30 | 9 | 30 |
| EG002 | Meperidine | 0 | 30 | 16 | 30 |
| Bradycardia | Cardiac disorders |
|
| Desaturation | Respiratory, thoracic and mediastinal disorders |
|
| Dizziness | Ear and labyrinth disorders |
|
| Headache | Nervous system disorders |
|
| Disinhibition | Psychiatric disorders |
|
| Amnesia | Nervous system disorders |
|
| Nausea | Gastrointestinal disorders |
|
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |