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

NCT03632330

Last updated date
Study Location
Pfizer Korea
Seoul, , , Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastrointestinal Endoscopy, Sedation, Dexmedetomidine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

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Gastrointestinal Endoscopy, Sedation, DexmedetomidineSedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis
NCT03632330
  1. Seoul,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Sedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis
Official Title SEDATION OF ADULT PATIENTS UNDERGOING GASTROINTESTINAL ENDOSCOPY: A NETWORK META-ANALYSIS
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Gastrointestinal Endoscopy
  • Sedation
  • Dexmedetomidine
Intervention
  • Drug: Dexmedetomidine
    Dexmedetomidine group
    Other Name: The group includes patients treated with Dexmedetomidine
  • Drug: Midazolam
    Midazolam group
    Other Name: The group includes patients treated with Midazolam
  • Drug: Propofol
    Propofol group
    Other Name: The group includes patients treated with Propofol
  • Drug: Midazolam/Propofol
    Midazolam/Propofol group
    Other Name: The group includes patients treated with Midazolam and propofol
Study Groups/Cohorts
  • Dexmedetomidine
    Dexmedetomidine group
    Intervention: Drug: Dexmedetomidine
  • Midazolam
    Midazolam group
    Intervention: Drug: Midazolam
  • propofol
    propofol group
    Intervention: Drug: Propofol
  • Midazolam/Propofol
    Midazolam and Propofol group
    Intervention: Drug: Midazolam/Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 25, 2019)
6963
Original Actual Enrollment
 (submitted: August 14, 2018)
7057
Actual Study Completion Date March 7, 2018
Actual Primary Completion Date March 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • 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.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03632330
Other Study ID Numbers C0801043
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2019