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OpenTrials
Completed

NCT Number: NCT03632330

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

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.

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Key information

Conditions

Gastrointestinal Endoscopy Dexmedetomidine Sedation

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Korea

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine group

Other names: The group includes patients treated with Dexmedetomidine

midazolam

Drug

Midazolam group

Other names: The group includes patients treated with Midazolam

Propofol

Drug

Propofol group

Other names: The group includes patients treated with Propofol

Midazolam/Propofol

Drug

Midazolam/Propofol group

Other names: The group includes patients treated with Midazolam and propofol

Primary outcomes

  1. Number of subjects who experience desaturation

    Time frame: 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 outcomes

  1. Number of subjects who experience Hypotension

    Time frame: 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%

  2. Number of subjects who experience Bradycardia

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2018
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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