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Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation.
This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).
70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol | Experimental | Patients in Group Propofol(n=70) were seated with propofol target concentration 1.2-1.6 µg/ml. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control. |
|
| midazolam | Active Comparator | Control Group: patients in Group midazolam (n=70) were sedated with midazolam 0.04 mg/kg if aged< 70 - 0.03 mg/kg if aged> 70. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug |
| ||
| Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation | Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100). | one day |
| Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation | Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100). | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (number of partecipants with adverse events) of propofol TCI moderate sedation | To compare safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists. | one day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Agostoni, MD | San Raffele Hospital | Study Director |
| Lorella Fanti, MD | San Raffaele Hospital | Principal Investigator |
| Marco Gemma, MD | San Raffaele Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | Milan | 20132 | Italy | ||
| San Raffaele Hospital |
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|
| Target Controlled Infusion | Device |
|
| Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients |
To compare time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients in group standard versus propofol TCI group safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists. |
| one day |
| Milan |
| Italy |
| ID | Term |
|---|---|
| D015742 | Propofol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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