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The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Modified propofol (Propofol 0.5%) |
|
| 2 | Active Comparator | Propofol 1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Propofol (drug), intravenous, induction of anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Expression of Pain During Injection | during first propofol bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Further Assessment of Injection Pain | during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Soltész, MD, PhD | Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH | Leverkusen | North Rhine-Westphalia | 51375 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22012178 | Derived | Soltesz S, Diekmann M, Mitrenga-Theusinger A, Keilen M, Molter GP. Reduced pain on injection with a 0.5% propofol emulsion during induction of anesthesia. Eur J Anaesthesiol. 2012 Mar;29(3):162-3. doi: 10.1097/EJA.0b013e32834cfa7d. No abstract available. |
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First patient in: 07.05.2008 Last patient out: 24.09.2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Propofol | Modified propofol (Propofol 0.5%) |
| FG001 | Propofol 1% | Propofol 1% |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Propofol | Modified propofol (Propofol 0.5%) |
| BG001 | Propofol 1% | Propofol 1% |
| 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 | Incidence of Expression of Pain During Injection | per protocol | Posted | Number | participants | during first propofol bolus |
|
|
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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 | Modified Propofol | Modified propofol (Propofol 0.5%) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypertriglyceridaemia | Metabolism and nutrition disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study manager | B.Braun Melsungen AG | +49 5661 71 | 0 | studies@bbraun.com |
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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 |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol 1% | Drug | Propofol (drug), intravenous, induction of anesthesia |
|
|
| BG002 |
| 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 | Further Assessment of Injection Pain | Not Posted | during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia |
| 0 |
| 50 |
| 44 |
| 50 |
| EG001 | Propofol 1% | Propofol 1% | 0 | 50 | 26 | 50 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |