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

Not Applicable

• Conditions: Endoscopy
• Interventions: Drug: Chlorpheniramine and midazolam; Drug: Midazolam

• Registration Number: NCT03940391
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-04-24
• Study Start: 2019-05-01
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Status Verified: 2020-04
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antihistamine combination	Chlorpheniramine and midazolam	Participants in this group will get combination chlorpheniramine and midazolam injection for sedative endoscopy.
midazolam	Midazolam	Participants in this group will get only midazolam injection for sedative endoscopy

Primary Outcome Measures

Name	Time	Method
Occurrence of severe paradoxical reaction (>= level 3)	1 day	(1) irrational talking or increased talkativeness such as mumbling to himself/herself; (2) restlessness or loss of cooperation such as resisting the insertion of endoscope or trying to bite the scope; (3) excessive movement requiring repositioning such as jerking or swinging movements of the arms and legs or trying to draw out the scope or mouthpiece; and (4) hostile action such as trying to strike the endoscopists or attending nurses.

Secondary Outcome Measures

Name	Time	Method
completeness of procedure	1 day	photo documentation of key anatomical area
adverse events	1 day	hypoxia, arrythmia, low blood pressure and administration of antidote
Dose of midazolam	1 day	total amount of benzodiazepine
Satisfaction for the procedure	1 day	5-point Likert scale for pain and sedation: patients; 1. Strongly unsatisfied; 2. Unsatisfied; 3. Neither satisfied nor unsatisfied; 4. Satisfied; 5. Strongly satisfied
procedure/intubation time	1 day	procedural time (time from scope insertion to scope out) Intubation time (time from scope insertion to upper esophagus)
Satisfaction for Quality of sedation	1 day	5-point Likert scale : endoscopists and assistant nurses; 1. Strongly unsatisfied; 2. Unsatisfied; 3. Neither satisfied nor unsatisfied; 4. Satisfied; 5. Strongly satisfied

Trial Locations

Locations (1)

Healthcare System Gangnam Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of