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

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.

Study Overview

• Status: Completed
• Conditions: Sedation; Gastrointestinal Endoscopy; Dexmedetomidine
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam; Drug: Propofol; Drug: Midazolam/Propofol

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
• Enrollment (Actual): 6963

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Pfizer Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dexmedetomidine; Dexmedetomidine group	Drug: Dexmedetomidine; Dexmedetomidine group; Other Names: The group includes patients treated with Dexmedetomidine
Midazolam; Midazolam group	Drug: Midazolam; Midazolam group; Other Names: The group includes patients treated with Midazolam
propofol; propofol group	Drug: Propofol; Propofol group; Other Names: The group includes patients treated with Propofol
Midazolam/Propofol; Midazolam and Propofol group	Drug: Midazolam/Propofol; Midazolam/Propofol group; Other Names: The group includes patients treated with Midazolam and propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects who experience Hypotension	BP<90/50, decrease>20% or 10mmHg, MAP<60mmHg or MAP decrease>20%	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%	From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): March 7, 2018
• Study Completion (Actual): March 7, 2018

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Propofol; Dexmedetomidine
• Other Study ID Numbers: C0801043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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/data_requests.