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The Sponsor has no interest in continuing the study.
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| Name | Class |
|---|---|
| Professor Fernando Figueira Integral Medicine Institute | OTHER |
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The purpose of this study is to compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.
Nanoemulsion of propofol has been developed without lipid solvent in the formulation to minimize the adverse events such as pain of injection, redness, heat, phlebitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol nanoemulsion | Experimental | 3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given. |
|
| propofol lipid emulsion | Active Comparator | 3-4 mg/kg will be administered by 1 ml per 5 seconds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | 3 - 4 mg/kg IV, adjustment dose if necessary |
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| Measure | Description | Time Frame |
|---|---|---|
| Classification of the sedation level | Instantly after the loss of consciousness (loss of corneal-palpebral reflex) will be measured the sedation using the Ramsay Modified Scale. | time 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of latency | Time between the injection and loss of the corneal-palpebral reflex | 3-10 seconds |
| Pain at injection | The pain will be measured by CHEOPS Scale which evaluates the behavior of the child against pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciana C Lima, PhD | IMIP | Principal Investigator |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 3 - 10 seconds: during the injection |
| Physician satisfaction | The satisfaction of the medical specialist will be assessed through a questionnaire that assesses conditions of sedation for the procedure. | 12 hours: end of procedure |
| Awakening time | Time between the last dose of propofol and the time when the patient awakes (cry, eyes opening and spontaneous movement). | 10 hours: when the patient awakes |
| Total dose | The total dose used will be measured in mg/kg/hour. | 12 - hours End of procedure |
| Incidence of Adverse Events | Adverse events will be compared in its incidence in the two formulations of propofol during the anesthetic induction and 12 hours after the procedures. | 0 to 14 hours |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |