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

Endoscopy Clinical Trial

Official title:

Effect of an Adjunctive Sedative for the Patients With Histories of Paradoxical Reaction to Midazolam During Sedative Endoscopy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03940391
• Other study ID #: H-1093-054-1017
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: April 14, 2020

Study information

• Verified date: April 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 220
• Est. completion date: April 14, 2020
• Est. primary completion date: April 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopy

Intervention

Drug:
• Chlorpheniramine and midazolam
Administration of chlorpheniramine injection as an adjunctive sedative during sedative endoscopy.
• Midazolam
Administration of midazolam as a sedative during sedative endoscopy as routine clinical practice.

Locations

Country	Name	City	State
Korea, Republic of	Healthcare System Gangnam Center, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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 201 — View Citation

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 J — View Citation

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.d — View Citation

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. — View Citation

Outcome

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