Endoscopy, Moderate Sedation
Conditions
Brief 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.
Interventions
PROCEDUREEGD and colonoscopy
Cold forceps biopsy, cold snare polypectomy, and/or hot snare polypectomy will be performed for stomach and/or colon polyps during EGD and colonoscopy examinations will be performed whenever indicated.
Sponsors
Evergreen General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedative Doses of Fentanyl | On the day of endoscopic procedures. | During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups. |
| Sedative Doses of Midazolam | On the day of bidirectional endoscopy procedures | During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Duration of BDE Examinations | On the day of bidirectional endoscopy | The overall duration of both EGD and colonoscopy examinations was recorded and compared. |
Participant flow
Recruitment details
Total 129 patients were invited to participate in the study from April to July 2016, and 8 patients were excluded. Finally, 121 patients were recruited for the study which was performed in a community hospital (Evergreen General Hospital). One patient in the EGD-colonoscopy was further excluded from final analysis due to poor bowel preparation.
Pre-assignment details
Eight patients were excluded from assignment due to refusal to provide informed consent (n=3), American Society of Anesthesiology class 3 (n=3), duodenal peptic stricture (n =1), and partial colectomy (n=1).
Participants by arm
| Arm | Count |
|---|---|
| EGD-colonoscopy Group In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded. | 60 |
| Colonoscopy-EGD Group In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | EGD-colonoscopy Group | Colonoscopy-EGD Group | Total |
|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 11.1 | 52.9 years STANDARD_DEVIATION 12.7 | 53.7 years STANDARD_DEVIATION 11.9 |
| Gender Female | 34 Participants | 30 Participants | 64 Participants |
| Gender Male | 26 Participants | 30 Participants | 56 Participants |
| Region of Enrollment Taiwan | 60 participants | 60 participants | 120 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 60 | 20 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Sedative Doses of Fentanyl
During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.
Time frame: On the day of endoscopic procedures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGD-colonoscopy Group | Sedative Doses of Fentanyl | 1.09 mcg/kg | Standard Deviation 0.42 |
| Colonoscopy-EGD Group | Sedative Doses of Fentanyl | 1.28 mcg/kg | Standard Deviation 0.31 |
Comparison: The two-sample t test will be used to compare the total doses of fentanyl and midazolam between the two study groups.p-value: <0.0001t-test, 2 sided
Primary
Sedative Doses of Midazolam
During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.
Time frame: On the day of bidirectional endoscopy procedures
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGD-colonoscopy Group | Sedative Doses of Midazolam | 0.08 mg/kg | Standard Deviation 0.03 |
| Colonoscopy-EGD Group | Sedative Doses of Midazolam | 0.10 mg/kg | Standard Deviation 0.02 |
Comparison: The two-sample t test will be used to compare the total doses of midazolam between the two study groups.p-value: 0.0012t-test, 2 sided
Secondary
Overall Duration of BDE Examinations
The overall duration of both EGD and colonoscopy examinations was recorded and compared.
Time frame: On the day of bidirectional endoscopy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGD-colonoscopy Group | Overall Duration of BDE Examinations | 32.7 minutes | Standard Deviation 9.9 |
| Colonoscopy-EGD Group | Overall Duration of BDE Examinations | 33.3 minutes | Standard Deviation 7.5 |
p-value: 0.6967t-test, 2 sided