Effect of the Antihistamine Injection to Prevent Paradoxical Reaction During Sedative Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-04-14

Brief Summary

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This single-blind prospective study is aimed to investigate the effect of antihistamine as an adjunctive sedative for the patients with histories of severe paradoxical reaction to midazolam during sedative endoscopy. Participating patients are to receive antihistamine intravenously in addition to midazolam. The primary outcome is the reduction of paradoxical reaction in the antihistamine combination group. The secondary outcome is to compare sedation quality, performance quality, reduction of total midazolam dose will be analyzed between antihistamine combination and midazolam only group.

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Detailed Description

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The present study will be conducted at Seoul National University Hospital Gangnam center between May 2019 and April 2020. Participants who have histories of paradoxical reaction to sedative endoscopy in medical record gave consent on the day of the endoscopy and were assigned to receive the combination of chlorpheniramine (4-6mg) with midazolam(1-10mg) Meanwhile, the patients do not want the use of chlorpheniramine and were assigned to midazolam alone as routine clinical practice. Research medication (chlorpheniramine) was administered 2 to 3 minutes before the administration of midazolam outside of endoscopy room. The blinded endoscopist and assistant nurse are going to perform induction for moderate sedation using incremental doses of the intravenous midazolam (1-2 mg) given every 2 minutes. The endoscopists and assistant nurses will assess the occurrence of severe paradoxical reaction (Grade 3) and other major quality outcomes (procedure/intubation time, sedation quality, completeness of procedure \[10 Key image documentation\], the satisfaction of procedure, side effects). The endoscopists and nurses will individually rate outcome measure using a 5-point Likert scale.

Conditions

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Endoscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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antihistamine combination

Participants in this group will get combination chlorpheniramine and midazolam injection for sedative endoscopy.

Group Type EXPERIMENTAL

Chlorpheniramine and midazolam

Intervention Type DRUG

Administration of chlorpheniramine injection as an adjunctive sedative during sedative endoscopy.

midazolam

Participants in this group will get only midazolam injection for sedative endoscopy

Group Type PLACEBO_COMPARATOR

Midazolam

Intervention Type DRUG

Administration of midazolam as a sedative during sedative endoscopy as routine clinical practice.

Interventions

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Chlorpheniramine and midazolam

Administration of chlorpheniramine injection as an adjunctive sedative during sedative endoscopy.

Intervention Type DRUG

Midazolam

Administration of midazolam as a sedative during sedative endoscopy as routine clinical practice.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previous histories of the paradoxical reaction during a sedative endoscopic examination

Exclusion Criteria

* inability to execute informed consent
* allergic to antihistamine agent
* pregnancy
* severe cardiopulmonary disease
* prior administration of antihistamine on the same day

Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes