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The objective of this study is to compare the efficacy and safety of dexmedetomidine with other sedatives in sedation during endoscopy by analyzing the most recently published interventional trials and observational studies.
A variety of sedatives are available in procedural sedation and the efficacy & safety have been compared in several trials for procedural sedation. However, none of clinical trial has enough number of patients to clarify the conclusive differences among sedatives. Thus, pooling all available studies together systematically by network meta-analysis for GI endoscopic procedure may provide a better understanding of efficacy and safety of sedatives. Therefore we would like to conduct a network meta-analysis to analyze the outcomes of GI endoscopy by using the most recently-published interventional trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Dexmedetomidine group |
| |
| Midazolam | Midazolam group |
| |
| propofol | propofol group |
| |
| Midazolam/Propofol | Midazolam and Propofol group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine group |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who experience desaturation | SaO2 < 94% for more than 10 seconds, RR<8, apneic episodes, face mask | From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who experience Hypotension | BP<90/50, decrease>20% or 10mmHg, MAP<60mmHg or MAP decrease>20% | From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure |
| Number of subjects who experience Bradycardia |
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Two reviewers independently extract data, including outcomes of interests, demographics of the enrolled patients' population, inclusion and exclusion criteria for each study, the comparative drug used, the number of patients in each group, sedation target and posology.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Korea | Seoul | South Korea |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Midazolam | Drug | Midazolam group |
|
|
| Propofol | Drug | Propofol group |
|
|
| Midazolam/Propofol | Drug | Midazolam/Propofol group |
|
|
A heart rate of <50 beats per min, decrease > 15% |
| From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |