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Occurrence of severe respiratory depression in the remifentanil group.
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| Name | Class |
|---|---|
| Hospital de San Jose | OTHER |
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The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.
The administration of sedation with target controlled infusion (TCI) systems could offer a safe alternative for the management of discomfort of patients undergoing endoscopic gastrointestinal procedures. However, what medication from those available for TCI would be the most appropriate is not known.
Sixty-nine patients requiring a gastrointestinal endoscopic procedure were randomly assigned to receive a TCI effect site (e) of remifentanil (n=30) or propofol (n=39). The primary outcome was patient satisfaction. Secondary outcomes included gastroenterologist satisfaction, the proportion of adverse events between the two groups were compared (occurrence of cardiac arrhythmias, mild respiratory depression, major respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, and lack of amnesia), and the level of consciousness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil | Active Comparator | Remifentanil target controlled infusion effect site with Minto's pharmacokinetic model. Start dose: 1 ng/mL. Titration: 0.5 ng/mL according to clinical criteria. |
|
| Propofol | Active Comparator | Propofol target controlled infusion effect site with Marsh's pharmacokinetic model. Start dose: 1 mcg/mL. Titration: 0.5 mcg/mL according to clinical criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug |
| ||
| Propofol |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Measured with a analog scale from 1 to 4:
| At the end of the procedure, expected average of 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroenterologist satisfaction | Measured with a analog scale from 1 to 4:
| At the end of the procedure, expected average of 30 minutes |
| Adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Level of consciousness | Ramsay scale. | Every minute until the end of the procedure, expected average of 30 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis A Muñoz, MD | Fundacion Universitaria de Ciencias de la Salud | Study Director |
| Luis E Reyes, MD | Fundacion Universitaria de Ciencias de la Salud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Universitaria de Ciencias de la Salud | Bogotá | Bogota D.C. | 11001000 | Colombia |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
Occurrence of cardiac arrythmias, mild respiratory depression, severe respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, absence of amnesia.
| At the end of the procedure, expected average of 30 minutes |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |