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NCT03632330 Clinical Trial

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

Sedation Clinical Trial

Official title:
SEDATION OF ADULT PATIENTS UNDERGOING GASTROINTESTINAL ENDOSCOPY: A NETWORK META-ANALYSIS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03632330
Other study ID # C0801043
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 5, 2018
Est. completion date March 7, 2018

Study information
Verified date July 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 6963
Est. completion date March 7, 2018
Est. primary completion date March 7, 2018
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility - 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine group
• Midazolam
Midazolam group
• Propofol
Propofol group
• Midazolam/Propofol
Midazolam/Propofol group

Locations
Country Name City State
Korea, Republic of Pfizer Korea Seoul

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
See also
  Status Clinical Trial Phase
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Completed NCT03220880 - Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Recruiting NCT04820205 - Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children N/A
Recruiting NCT04549623 - End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography N/A
Recruiting NCT04822064 - Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation N/A
Completed NCT01001533 - Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation N/A
Completed NCT01527903 - A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit Phase 4
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1
Completed NCT00158873 - Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects Phase 4
Terminated NCT00205517 - Sedation and Psychopharmacology in Critical Care N/A
Recruiting NCT04096768 - The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation Phase 3
Active, not recruiting NCT05082623 - The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters N/A
Suspended NCT03285165 - Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients Phase 2/Phase 3
Active, not recruiting NCT04788589 - Sedation and Ventilator Weaning Protocol in PICU N/A
Completed NCT03425474 - Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy Phase 3
Recruiting NCT06061159 - The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction Phase 4
Completed NCT06449365 - Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy Phase 4
Completed NCT02171910 - Doxapram as an Additive to Propofol Sedation in Sedation for ERCP Phase 4
Completed NCT02211118 - Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD Phase 4
Completed NCT01694745 - EUROpean Pain Audit In Neonates N/A

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