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

Completed

• Conditions: Gastrointestinal Endoscopy; Sedation; Dexmedetomidine
• Interventions: Drug: Midazolam/Propofol; Drug: Dexmedetomidine; Drug: Midazolam; Drug: Propofol

• Registration Number: NCT03632330
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-02-05
• Primary Completion: 2018-03-07
• Study Completion: 2018-03-07
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-15
• Status Verified: 2019-07
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6963

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Midazolam/Propofol	Midazolam/Propofol	Midazolam and Propofol group
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine group
Midazolam	Midazolam	Midazolam group
propofol	Propofol	propofol group

Primary Outcome Measures

Name	Time	Method
Number of subjects who experience desaturation	From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure.	SaO2 \< 94% for more than 10 seconds, RR\<8, apneic episodes, face mask

Secondary Outcome Measures

Name	Time	Method
Number of subjects who experience Hypotension	From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure	BP\<90/50, decrease\>20% or 10mmHg, MAP\<60mmHg or MAP decrease\>20%
Number of subjects who experience Bradycardia	From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure	A heart rate of \<50 beats per min, decrease \> 15%

Trial Locations

Locations (1)

Pfizer Korea; 🇰🇷 Seoul, Korea, Republic of