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

• Sponsor: DongGuk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04072328
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.1
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sedation; Endoscopy	Drug: Propofol; Drug: Midazolam	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam
• Actual Study Start Date: Oct 19, 2018
• Actual Primary Completion Date: Aug 10, 2020
• Actual Study Completion Date: Dec 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propofol alone Participants who receive propofol alone during sedative endoscopy.	Drug: Propofol; Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.
Active Comparator: Midazolam with propofol Participants who receive midazolam + propofol during sedative endoscopy.	Drug: Propofol; Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.; Drug: Midazolam; midazolam with propofol

Outcome Measures

Primary Outcome Measures

1. The prevalence of paradoxical response [At the end of endoscopy]

   The proportion of participants who show paradoxical response during endoscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• History of midazolam-induced paradoxical response

Exclusion Criteria:

• Failed to obtain informed consent

• Pregnant or breast feeding women

• A severe cardiopulmonary or vascular disease with symptoms

• Cognitive or mental impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dongguk University Ilsan Hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	10326

Sponsors and Collaborators

• DongGuk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Dong Kee Jang, Assistant Professor, DongGuk University
• ClinicalTrials.gov Identifier: NCT04072328
• Other Study ID Numbers: 2018-02-011
• First Posted: Aug 28, 2019
• Last Update Posted: Dec 29, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dong Kee Jang, Assistant Professor, DongGuk University: Midazolam; Propofol; Sedation
• Additional relevant MeSH terms: Midazolam; Propofol

Study Results

No Results Posted as of Dec 29, 2020