Endoscopy
Conditions
Keywords
paradoxical reaction, midazolam
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.
Interventions
DRUGChlorpheniramine and midazolam
Administration of chlorpheniramine injection as an adjunctive sedative during sedative endoscopy.
DRUGMidazolam
Administration of midazolam as a sedative during sedative endoscopy as routine clinical practice.
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Dose of midazolam | 1 day | total amount of benzodiazepine |
| completeness of procedure | 1 day | photo documentation of key anatomical area |
| 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 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 |
| adverse events | 1 day | hypoxia, arrythmia, low blood pressure and administration of antidote |
| 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 |
Countries
South Korea
Outcome results
None listed