Sedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis
SEDATION OF ADULT PATIENTS UNDERGOING GASTROINTESTINAL ENDOSCOPY: A NETWORK META-ANALYSIS
1 other identifier
observational
6,963
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2018
CompletedFirst Submitted
Initial submission to the registry
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedApril 6, 2023
July 1, 2019
1 month
July 30, 2018
April 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of subjects who experience Hypotension
From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure
Number of subjects who experience Bradycardia
From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure
Study Arms (4)
Dexmedetomidine
Dexmedetomidine group
Midazolam
Midazolam group
propofol
propofol group
Midazolam/Propofol
Midazolam and Propofol group
Interventions
Dexmedetomidine group
Midazolam group
Midazolam/Propofol group
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Korea
Seoul, South Korea
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2018
First Posted
August 15, 2018
Study Start
February 5, 2018
Primary Completion
March 7, 2018
Study Completion
March 7, 2018
Last Updated
April 6, 2023
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share
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.