Sedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SEDATION OF ADULT PATIENTS UNDERGOING GASTROINTESTINAL ENDOSCOPY: A NETWORK META-ANALYSIS

Conditions
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Gastrointestinal Endoscopy, Sedation, Dexmedetomidine

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam
* Drug: Propofol
* Drug: Midazolam/Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion criteria We will include studies if they (1) the setting was using any sedative for endoscopy for an procedural sedation (2) the study compared dexmedetomidine with other sedative for sedative therapy and (3) the outcomes included satisfaction score and adverse events. Exclusion criteria We excluded studies if they (1) the number of sedative was different in two arms (2) did not report the specific results comparing dexmedetomidine with other sedatives.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexmedetomidine<br>Dexmedetomidine group | Drug: Dexmedetomidine<br>* Dexmedetomidine group<br>* Other names: The group includes patients treated with Dexmedetomidine;|
| Midazolam<br>Midazolam group | Drug: Midazolam<br>* Midazolam group<br>* Other names: The group includes patients treated with Midazolam;|
| propofol<br>propofol group | Drug: Propofol<br>* Propofol group<br>* Other names: The group includes patients treated with Propofol;|
| Midazolam/Propofol<br>Midazolam and Propofol group | Drug: Midazolam/Propofol<br>* Midazolam/Propofol group<br>* Other names: The group includes patients treated with Midazolam and propofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |