An observational study in Gastrointestinal Endoscopy, Sedation and Dexmedetomidine, sponsored by Pfizer. Completed at 1 site in Korea, Republic of. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Pfizer · Observational
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Dexmedetomidine group
Drug: Dexmedetomidine
Midazolam group
Drug: Midazolam
propofol group
Drug: Propofol
Midazolam and Propofol group
Drug: Midazolam/Propofol
Dexmedetomidine group
Also known as: The group includes patients treated with Dexmedetomidine
Midazolam group
Also known as: The group includes patients treated with Midazolam
Propofol group
Also known as: The group includes patients treated with Propofol
Midazolam/Propofol group
Also known as: The group includes patients treated with Midazolam and propofol
Number of subjects who experience desaturation
SaO2 \< 94% for more than 10 seconds, RR\<8, apneic episodes, face mask
Time frame: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure.
Number of subjects who experience Hypotension
BP\<90/50, decrease\>20% or 10mmHg, MAP\<60mmHg or MAP decrease\>20%
Time frame: 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%
Time frame: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure
Plan to share: No — 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.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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