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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol group | Experimental | 70 patients (35 upper endoscopy - 35 colonoscopy) |
|
| midazolam group | Active Comparator | 70 patients (35 upper endoscopy - 35 colonoscopy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | 70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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) | at 24-72 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pier Alberto Testoni, Professor | Vita-Salute San Raffalele University- San Raffaele Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | Italy | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25840875 | Derived | Fanti L, Gemma M, Agostoni M, Rossi G, Ruggeri L, Azzolini ML, Dabizzi E, Beretta L, Testoni PA. Target Controlled Infusion for non-anaesthesiologist propofol sedation during gastrointestinal endoscopy: The first double blind randomized controlled trial. Dig Liver Dis. 2015 Jul;47(7):566-71. doi: 10.1016/j.dld.2015.03.003. Epub 2015 Mar 14. |
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Exclusion criteria were: significant systemic disease (ASA III-IV), allergic reactions to study drugs, chronic use of opioids, psychiatric disorders, pregnancy, difficult airways (Mallampati score >2), age <18 years.
A gastroenterology attending fellow (GF), not directly involved in the procedure, provided sedation.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol Group | A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient's body weight and general condition. 35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control. |
| FG001 | Midazolam Group | A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years). 35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol Group | 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient's body weight and general condition. 35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control. Patients in this group received placebo boluses with normal saline to warrant blindness to the randomization group of both patient and endoscopist. (because of the well-known difference in the physical appearance of the study drugs, to maintain blindness of endoscopist, a fabric curtain was drawn across patient's arm covering the i.v. line and TCI pump). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | at the end of the exam |
|
|
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Serious and other (non serious) adverse events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol Group; n=35, 35 | 35 upper endoscopy 35 colonoscopy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Testoni Pier Alberto | Università Vita-Salute San Raffaele | +390226432756 | testoni.pieralberto@hsr.it |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Midazolam | Drug | 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. |
|
| one day |
| Number of Participants With Adverse Events as a Measure of Safety | Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...) | one day |
| BG001 | Midazolam Group | 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years). 35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale | before discharge |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale | at 24-72 hours after procedure |
|
|
|
| Secondary | 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. | Not Posted | one day |
| Secondary | Number of Participants With Adverse Events as a Measure of Safety | Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...) | Not Posted | one day |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Midazolam Group; n=35, 35 | 35 upper endoscopy 35 colonoscopy | 0 | 70 | 0 | 70 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |