An interventional study of Chlorpheniramine and midazolam and Midazolam in Endoscopy, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Participants in this group will get combination chlorpheniramine and midazolam injection for sedative endoscopy.
Drug: Chlorpheniramine and midazolam
Participants in this group will get only midazolam injection for sedative endoscopy
Drug: Midazolam
Administration of chlorpheniramine injection as an adjunctive sedative during sedative endoscopy.
Administration of midazolam as a sedative during sedative endoscopy as routine clinical practice.
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.
Time frame: 1 day
procedure/intubation time
procedural time (time from scope insertion to scope out) Intubation time (time from scope insertion to upper esophagus)
Time frame: 1 day
Dose of midazolam
total amount of benzodiazepine
Time frame: 1 day
completeness of procedure
photo documentation of key anatomical area
Time frame: 1 day
Satisfaction for Quality of sedation
5-point Likert scale : endoscopists and assistant nurses 1. Strongly unsatisfied 2. Unsatisfied 3. Neither satisfied nor unsatisfied 4. Satisfied 5. Strongly satisfied
Time frame: 1 day
Satisfaction for the procedure
5-point Likert scale for pain and sedation: patients 1. Strongly unsatisfied 2. Unsatisfied 3. Neither satisfied nor unsatisfied 4. Satisfied 5. Strongly satisfied
Time frame: 1 day
adverse events
hypoxia, arrythmia, low blood pressure and administration of antidote
Time frame: 1 day
Plan to share: No
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital