NCT03940391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

12 months

First QC Date

April 24, 2019

Last Update Submit

April 15, 2020

Conditions

Endoscopy

Keywords

paradoxical reactionmidazolam

Outcome Measures

Primary Outcomes (1)

  • Occurrence of severe paradoxical reaction (>= level 3)

    (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.

    1 day

Secondary Outcomes (6)

  • procedure/intubation time

    1 day

  • Dose of midazolam

    1 day

  • completeness of procedure

    1 day

  • Satisfaction for Quality of sedation

    1 day

  • Satisfaction for the procedure

    1 day

  • +1 more secondary outcomes

Study Arms (2)

antihistamine combination

EXPERIMENTAL

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

Drug: Chlorpheniramine and midazolam

midazolam

PLACEBO COMPARATOR

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

Drug: Midazolam

Interventions

Chlorpheniramine and midazolamDRUG

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

antihistamine combination
MidazolamDRUG

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

midazolam

Eligibility Criteria

Age19 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (4)

  • Sachar H, Pichetshote N, Nandigam K, Vaidya K, Laine L. Continued midazolam versus diphenhydramine in difficult-to-sedate patients: a randomized double-blind trial. Gastrointest Endosc. 2018 May;87(5):1297-1303. doi: 10.1016/j.gie.2017.01.028. Epub 2017 Jan 31.

    PMID: 28159539RESULT

  • Nusrat S, Madhoun MF, Tierney WM. Use of diphenhydramine as an adjunctive sedative for colonoscopy in patients on chronic opioid therapy: a randomized controlled trial. Gastrointest Endosc. 2018 Oct;88(4):695-702. doi: 10.1016/j.gie.2018.04.2342. Epub 2018 Apr 22.

    PMID: 29689257RESULT

  • 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: 24893689RESULT

  • Tu RH, Grewall P, Leung JW, Suryaprasad AG, Sheykhzadeh PI, Doan C, Garcia JC, Zhang N, Prindiville T, Mann S, Trudeau W. Diphenhydramine as an adjunct to sedation for colonoscopy: a double-blind randomized, placebo-controlled study. Gastrointest Endosc. 2006 Jan;63(1):87-94. doi: 10.1016/j.gie.2005.08.015.

    PMID: 16377322RESULT

MeSH Terms

Interventions

ChlorpheniramineMidazolam

Intervention Hierarchy (Ancestors)

PheniraminePyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 7, 2019

Study Start

May 1, 2019

Primary Completion

April 14, 2020

Study Completion

April 14, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)