A Phase 4 interventional study of Propofol and Midazolam in Sedation and Endoscopy, sponsored by Università Vita-Salute San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-08.
Sponsored by Università Vita-Salute San Raffaele · Phase 4, Interventional, and Treatment
Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.
Università Vita-Salute San Raffaele is the lead sponsor of 84 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
70 patients (35 upper endoscopy - 35 colonoscopy)
Drug: Propofol
70 patients (35 upper endoscopy - 35 colonoscopy)
Drug: Midazolam
70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).
70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged \< 70, 0.03 mg/Kg if aged \> 70.
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist
Time frame: at the end of the exam
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge
When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)
Time frame: before discharge
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure
Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)
Time frame: at 24-72 hours after procedure
Time (Minutes) to Dischargeability of Patient From Endoscopic Unit
After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.
Time frame: one day
Number of Participants With Adverse Events as a Measure of Safety
Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)
Time frame: one day
140 consecutive outpatients were scheduled to undergo Upper Endoscopy (70 patients) or complete Colonoscopy (70 patients) from 17 th February 2014 to 5 th May 2014 in Endoscopy Unit of San Raffaele Hospital - Milan.
| Milestone | Propofol Group | Midazolam Group |
|---|---|---|
| Started | 70 | 70 |
| Completed | 70 | 70 |
| Not completed | 0 | 0 |
Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist
| units on a scale | Propofol Group; n=35, 35 | Midazolam Group; n=35, 35 |
|---|---|---|
| upper endoscopy | 93 ± 14 | 83 ± 21 |
| colonoscopy | 98 ± 11 | 87 ± 12 |
When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)
| units on a scale | Propofol Group; n=35, 35 | Midazolam Group; n=35, 35 |
|---|---|---|
| Upper endoscopy | 94 ± 18 | 76 ± 25 |
| Colonoscopy | 95 ± 9 | 85 ± 14 |
Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)
| units on a scale | Propofol Group; n=35, 35 | Midazolam Group; n=35, 35 |
|---|---|---|
| Upper endoscopy | 93 ± 20 | 77 ± 27 |
| Colonoscopy | 97 ± 9 | 88 ± 16 |
After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.
Results for this outcome have not been posted.
Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propofol Group; n=35, 35 | — | 0/70 (0%) | 0/70 (0%) |
| Midazolam Group; n=35, 35 | — | 0/70 (0%) | 0/70 (0%) |
| Age, Categorical(Participants) | Propofol Group | Midazolam Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 55 | 57 | 112 |
| >=65 years | 15 | 13 | 28 |
| Sex: Female, Male(Participants) | Propofol Group | Midazolam Group | Total |
|---|---|---|---|
| Female | 30 | 32 | 62 |
| Male | 40 | 38 | 78 |
| Region of Enrollment(participants) | Propofol Group | Midazolam Group | Total |
|---|---|---|---|
| Italy | 70 | 70 | 140 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Università Vita-Salute San Raffaele