EGD Procedure
Conditions
Keywords
sedation, propofol, midazolam
Brief summary
Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this study, the investigators want to compare the patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone.
Interventions
DRUGMidazolam + propofol
Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol.
DRUGpropofol
propofol are used for sedation drug
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. over 19 years old, male and female 2. patients who have plan to get esophagogastroduodenoscopy (EGD)
Exclusion criteria
1. ASA class III or IV 2. Allergies to propofol, sulfites or eggs 3. patients who had surgery for esophagus, stomach or duodenum 4. inpatients 5. patients who had sleep apnea, gastroparesis or achalasia 6. patients who are taking sedative drugs more than 6 months 7. pregnancy 8. hypotension (systolic pressure less than 90mmHg), bradycardia (pulse rates less than 50 times per minute) or hypoxia (SpO2 less than 90%) 9. psychiatric or neurologic problems (ex. epilepsy or dementia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale | Within the 24 hours after EGD | The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complications rates | Within the 1 hour after EGD | The recovery time after EGD following balanced propofol sedation versus propofol sedation alone. The safety after EGD following balanced propofol sedation versus propofol sedation alone |
Other
| Measure | Time frame | Description |
|---|---|---|
| complications rates | Within the 1 hour after EGD | The safety after EGD following balanced propofol sedation versus propofol sedation alone |
| total dose of the sedation drugs | Within the 1 hour after EGD | The economy after EGD following balanced propofol sedation versus propofol sedation alone |
| visual analog scale | Within the 1 hour after EGD | The endoscopist's satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone |
Countries
South Korea
Outcome results
None listed