N/A
N=120
Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: A Prospective Randomized Controlled Study
Endoscopy · Moderate Sedation
Bottom Line
View on ClinicalTrials.gov: NCT02708212 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Sedative Doses of Fentanyl — 1.09; 1.28 mcg/kg — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EGD and colonoscopy (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Evergreen General Hospital, Taiwan
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sedative Doses of Fentanyl |
1.09; 1.28 | <0.0001 sig |
| PRIMARY Sedative Doses of Midazolam |
0.08; 0.10 | 0.0012 sig |
| SECONDARY Overall Duration of BDE Examinations |
32.7; 33.3 | 0.6967 |
Summary
The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However, the optimal sequence of performing a same-day BDE has not been well-established.The primary aims of this study are to compare the sedative doses and patient discomfort between the study groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD followed by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to assess colonoscopy performance, including the cecal intubation time and adenoma detection rate between the two endoscopic sequences.
Eligibility Criteria
Inclusion Criteria
- Outpatients, aged 20 to 75 years, who are scheduled for same-day bidirectional endoscopy examination for any indication are invited to participate in the study.
Exclusion Criteria
- 1. previous gastrectomy or colectomy 2. inadequate bowel preparation, 3. obstructive lesions of the colon 4. severe colitis, gastrointestinal bleeding 5. allergy to fentanyl or midazolam 6. American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher, 7. mental retardation 8. regular use of narcotics 9. pregnancy 10. refusal to provide a written informed consent.
Data sourced from ClinicalTrials.gov (NCT02708212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.