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

Seoul National University

Status: Unknown

Conditions: Endoscopy

Treatments: Drug: Chlorpheniramine and midazolam; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03940391

H-1093-054-1017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 19 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 2 patient groups, including a placebo group

antihistamine combination

Experimental group

Description:

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

Treatment:

Drug: Chlorpheniramine and midazolam

midazolam

Placebo Comparator group

Description:

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

Treatment:

Drug: Midazolam