Effect of the Antihistamine Injection to Prevent Paradoxical Reaction During Sedative Endoscopy
15. april 2020 opdateret af: Su Jin Chung, Seoul National University Hospital
Effect of an Adjunctive Sedative for the Patients With Histories of Paradoxical Reaction to Midazolam During Sedative Endoscopy
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
220
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Seoul, Korea, Republikken
- Healthcare System Gangnam Center, Seoul National University Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år til 69 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: antihistamine combination
Participants in this group will get combination chlorpheniramine and midazolam injection for sedative endoscopy.
|
Administration of chlorpheniramine injection as an adjunctive sedative during sedative endoscopy.
|
|
Placebo komparator: midazolam
Participants in this group will get only midazolam injection for sedative endoscopy
|
Administration of midazolam as a sedative during sedative endoscopy as routine clinical practice.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurrence of severe paradoxical reaction (>= level 3)
Tidsramme: 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.
|
1 day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
procedure/intubation time
Tidsramme: 1 day
|
procedural time (time from scope insertion to scope out) Intubation time (time from scope insertion to upper esophagus)
|
1 day
|
|
Dose of midazolam
Tidsramme: 1 day
|
total amount of benzodiazepine
|
1 day
|
|
completeness of procedure
Tidsramme: 1 day
|
photo documentation of key anatomical area
|
1 day
|
|
Satisfaction for Quality of sedation
Tidsramme: 1 day
|
5-point Likert scale : endoscopists and assistant nurses
|
1 day
|
|
Satisfaction for the procedure
Tidsramme: 1 day
|
5-point Likert scale for pain and sedation: patients
|
1 day
|
|
adverse events
Tidsramme: 1 day
|
hypoxia, arrythmia, low blood pressure and administration of antidote
|
1 day
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2019
Primær færdiggørelse (Forventet)
14. april 2020
Studieafslutning (Forventet)
14. april 2020
Datoer for studieregistrering
Først indsendt
24. april 2019
Først indsendt, der opfyldte QC-kriterier
6. maj 2019
Først opslået (Faktiske)
7. maj 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. april 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. april 2020
Sidst verificeret
1. april 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Bedøvelsesmidler, intravenøst
- Bedøvelsesmidler, general
- Bedøvelsesmidler
- Dermatologiske midler
- Beroligende midler
- Psykotropiske stoffer
- Hypnotika og beroligende midler
- Adjuvanser, anæstesi
- Anti-angst midler
- GABA modulatorer
- GABA agenter
- Anti-allergiske midler
- Histamin H1-antagonister
- Histaminantagonister
- Histaminmidler
- Kløestillende midler
- Midazolam
- Chlorpheniramin
Andre undersøgelses-id-numre
- H-1093-054-1017
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