Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam

NCT04072328 | Completed Phase 2

• 1 other identifier: 2018-02-011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to compare propofol vs. midazolam with propofol for sedative endoscopy in patients with previous paradoxical reaction to midazolam. Patients who meet eligibility criteria will randomly assigned to propofol group or midazolam with propofol group. Then they will receive a sedative endoscopy with close monitoring. The primary outcome is the prevalence of paradoxical response during endoscopy.

Conditions

Sedation; Endoscopy

Keywords

Midazolam; Propofol; Sedation

Outcome Measures

Primary Outcomes (1)

• The prevalence of paradoxical response

  The proportion of participants who show paradoxical response during endoscopy

  At the end of endoscopy

Study Arms (2)

Propofol alone

EXPERIMENTAL

Participants who receive propofol alone during sedative endoscopy.

Drug: Propofol

Midazolam with propofol

ACTIVE COMPARATOR

Participants who receive midazolam + propofol during sedative endoscopy.

Drug: Propofol; Drug: Midazolam

Interventions

Propofol DRUG

Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.

Midazolam with propofol; Propofol alone

Midazolam DRUG

midazolam with propofol

Midazolam with propofol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of midazolam-induced paradoxical response

You may not qualify if:

• Failed to obtain informed consent
• Pregnant or breast feeding women
• A severe cardiopulmonary or vascular disease with symptoms
• Cognitive or mental impairment

Sponsors & Collaborators

• DongGuk University: lead

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

Related Publications (3)

• Lee TH, Lee CK, Park SH, Lee SH, Chung IK, Choi HJ, Cha SW, Moon JH, Cho YD, Hwangbo Y, Kim SJ. Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures. Dig Dis Sci. 2012 Aug;57(8):2113-21. doi: 10.1007/s10620-012-2234-0. Epub 2012 May 22.

  PMID: 22615018 BACKGROUND

• Tae CH, Kang KJ, Min BH, Ahn JH, Kim S, Lee JH, Rhee PL, Kim JJ. Paradoxical reaction to midazolam in patients undergoing endoscopy under sedation: Incidence, risk factors and the effect of flumazenil. Dig Liver Dis. 2014 Aug;46(8):710-5. doi: 10.1016/j.dld.2014.04.007. Epub 2014 Jun 2.

  PMID: 24893689 RESULT

• Mancuso CE, Tanzi MG, Gabay M. Paradoxical reactions to benzodiazepines: literature review and treatment options. Pharmacotherapy. 2004 Sep;24(9):1177-85. doi: 10.1592/phco.24.13.1177.38089.

  PMID: 15460178 RESULT

MeSH Terms

Interventions

Propofol; Midazolam

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: October 19, 2018
• Primary Completion: August 10, 2020
• Study Completion: December 20, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)