Trial Outcomes & Findings for Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: A Prospective Randomized Controlled Study (NCT NCT02708212)
NCT ID: NCT02708212
Last Updated: 2017-02-01
Results Overview
During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
On the day of endoscopic procedures.
Results posted on
2017-02-01
Participant Flow
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.
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).
Participant milestones
| Measure |
EGD-colonoscopy Group
In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insullfation. 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.
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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 modeate 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.
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|---|---|---|
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Overall Study
STARTED
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60
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60
|
|
Overall Study
COMPLETED
|
60
|
60
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: A Prospective Randomized Controlled Study
Baseline characteristics by cohort
| Measure |
EGD-colonoscopy Group
n=60 Participants
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.
|
Colonoscopy-EGD Group
n=60 Participants
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.
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Total
n=120 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
54.5 years
STANDARD_DEVIATION 11.1 • n=93 Participants
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52.9 years
STANDARD_DEVIATION 12.7 • n=4 Participants
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53.7 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Gender
Female
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34 Participants
n=93 Participants
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30 Participants
n=4 Participants
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64 Participants
n=27 Participants
|
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Gender
Male
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26 Participants
n=93 Participants
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30 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
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Region of Enrollment
Taiwan
|
60 participants
n=93 Participants
|
60 participants
n=4 Participants
|
120 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: On the day of endoscopic procedures.During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.
Outcome measures
| Measure |
EGD-colonoscopy Group
n=60 Participants
In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study.
|
Colonoscopy-EGD Group
n=60 Participants
In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study.
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|---|---|---|
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Sedative Doses of Fentanyl
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1.09 mcg/kg
Standard Deviation 0.42
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1.28 mcg/kg
Standard Deviation 0.31
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PRIMARY outcome
Timeframe: On the day of bidirectional endoscopy proceduresDuring bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.
Outcome measures
| Measure |
EGD-colonoscopy Group
n=60 Participants
In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study.
|
Colonoscopy-EGD Group
n=60 Participants
In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study.
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|---|---|---|
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Sedative Doses of Midazolam
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0.08 mg/kg
Standard Deviation 0.03
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0.10 mg/kg
Standard Deviation 0.02
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SECONDARY outcome
Timeframe: On the day of bidirectional endoscopyThe overall duration of both EGD and colonoscopy examinations was recorded and compared.
Outcome measures
| Measure |
EGD-colonoscopy Group
n=60 Participants
In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study.
|
Colonoscopy-EGD Group
n=60 Participants
In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.
EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study.
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|---|---|---|
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Overall Duration of BDE Examinations
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32.7 minutes
Standard Deviation 9.9
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33.3 minutes
Standard Deviation 7.5
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Adverse Events
EGD-colonoscopy Group
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Colonoscopy-EGD Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EGD-colonoscopy Group
n=60 participants at risk
Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: \< 90% persisting for more than 60 s; 2) hypotension: \< 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: \> 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: \> 120 beats per minute, lasting more than 60 s; and 5) bradycardia: \< 50 beats per minute, lasting more than 60 s.
|
Colonoscopy-EGD Group
n=60 participants at risk
Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: \< 90% persisting for more than 60 s; 2) hypotension: \< 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: \> 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: \> 120 beats per minute, lasting more than 60 s; and 5) bradycardia: \< 50 beats per minute, lasting more than 60 s.
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|---|---|---|
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Vascular disorders
Transient hypotension
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31.7%
19/60 • Number of events 19 • From the start of bidirectional endoscopy to one hour after the completion of the bidirectional endoscopy.
The adverse events during moderate sedation were usually transient and related to overall sedative doses. The primary aim of the study was to compared the overall sedative doses between the patients receiving EGD-colonoscopy and colonoscopy-EGD sequences. Theoretically, patients who received less sedative doses should experience less episodes of adverse events. Therefore, we calculated the overall sedative doses and adverse events after the completion of both EGD and colonoscopy examinations.
|
33.3%
20/60 • Number of events 20 • From the start of bidirectional endoscopy to one hour after the completion of the bidirectional endoscopy.
The adverse events during moderate sedation were usually transient and related to overall sedative doses. The primary aim of the study was to compared the overall sedative doses between the patients receiving EGD-colonoscopy and colonoscopy-EGD sequences. Theoretically, patients who received less sedative doses should experience less episodes of adverse events. Therefore, we calculated the overall sedative doses and adverse events after the completion of both EGD and colonoscopy examinations.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place