Gastrointestinal Endoscopy, Gastrointestinal Polypectomy
Conditions
Keywords
propofol endoscopy sedation
Brief summary
Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.
Interventions
DRUGPlacebo
Infusion of placebo, same infusion rates as for arm 2
DRUGICI35,868 (propofol)
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
Sponsors
Johnson & Johnson K.K. Medical Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female (females of child bearing potential to confirm not pregnant via test or contraception) * Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour
Exclusion criteria
* American Society of Anesthesiologists (ASA) grade III, IV V and VI * Baseline oxygen saturation\<90% (room air) * Body Mass Index (BMI) \>=35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | 2 minutes from the beginning of the maintenance period | The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5. |
| Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | 4 minutes from the beginning of the maintenance period | The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | 24 - 48 hours after completion of the procedure | The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied). |
| Blood Concentrations of Propofol | At the end of the initiation period and every 2 minutes during the maintenance period | Blood concentration of ICI35,868 (propofol) |
| Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7) | The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5. |
Countries
Japan
Participant flow
Recruitment details
A total of 2 centers were initiated with first patient enrolled on 23 August 2010 and last patient completed on 17 November. A total of 129 patients were enrolled with 123 qualified patients allocated to randomized treatment.
Pre-assignment details
The patients enrolled in this study were undergoing non-emergent standard esophagogastroduodenoscopy (EGD) or colonoscopy. Six patients were withdrawn from the study after enrollment but before randomization: 5 patients due to excess recruitment and one patient due to investigator's recommendation..
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Placebo Infusion of placebo, same infusion rates as for arm 2 | 20 |
| Arm 2 - ICI35,868 (Propofol) Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute | 20 |
| Arm 3 - ICI35,868 (Propofol) Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute | 20 |
| Arm 4 - ICI35,868 (Propofol) Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute | 20 |
| Arm 5 - ICI35,868 (Propofol) Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute | 20 |
| Arm 6 - ICI35,868 (Propofol) Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute | 10 |
| Arm 7 - ICI35,868 (Propofol) Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute | 10 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 2 | 0 | 1 |
| Overall Study | Impossible to visit | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 1 - Placebo | Arm 2 - ICI35,868 (Propofol) | Arm 3 - ICI35,868 (Propofol) | Arm 4 - ICI35,868 (Propofol) | Arm 5 - ICI35,868 (Propofol) | Arm 6 - ICI35,868 (Propofol) | Arm 7 - ICI35,868 (Propofol) | Total |
|---|---|---|---|---|---|---|---|---|
| Age Continuous | 53.2 years STANDARD_DEVIATION 17.3 | 51.0 years STANDARD_DEVIATION 16.4 | 56.1 years STANDARD_DEVIATION 14.4 | 52.0 years STANDARD_DEVIATION 14.9 | 56.4 years STANDARD_DEVIATION 12.7 | 49.4 years STANDARD_DEVIATION 14.2 | 51.8 years STANDARD_DEVIATION 8.5 | 53.2 years STANDARD_DEVIATION 14.5 |
| Procedures Colonoscopy | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 5 participants | 5 participants | 60 participants |
| Procedures Esophagogastroduodenoscopy (EGD) | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 5 participants | 5 participants | 60 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 10 Participants | 6 Participants | 9 Participants | 2 Participants | 5 Participants | 48 Participants |
| Sex: Female, Male Male | 14 Participants | 10 Participants | 10 Participants | 14 Participants | 11 Participants | 8 Participants | 5 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 20 | 0 / 20 | 0 / 20 | 1 / 20 | 6 / 20 | 1 / 10 | 2 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Time frame: 2 minutes from the beginning of the maintenance period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Placebo | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 20 Participants |
| Arm 1 - Placebo | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 0 Participants |
| Arm 1 - Placebo | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 2 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 2 Participants |
| Arm 2 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 2 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 18 Participants |
| Arm 3 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 14 Participants |
| Arm 3 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 3 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 6 Participants |
| Arm 4 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 6 Participants |
| Arm 4 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 1 Participants |
| Arm 4 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 13 Participants |
| Arm 5 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 14 Participants |
| Arm 5 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 1 Participants |
| Arm 5 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 5 Participants |
| Arm 6 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 1 Participants |
| Arm 6 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 4 Participants |
| Arm 6 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 5 Participants |
| Arm 7 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 7 Participants |
| Arm 7 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 3 Participants |
| Arm 7 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 0 Participants |
Primary
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Time frame: 4 minutes from the beginning of the maintenance period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Placebo | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 20 Participants |
| Arm 1 - Placebo | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 0 Participants |
| Arm 1 - Placebo | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 2 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 1 Participants |
| Arm 2 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 2 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 19 Participants |
| Arm 3 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 13 Participants |
| Arm 3 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 3 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 7 Participants |
| Arm 4 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 6 Participants |
| Arm 4 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 1 Participants |
| Arm 4 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 13 Participants |
| Arm 5 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 16 Participants |
| Arm 5 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 3 Participants |
| Arm 5 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 1 Participants |
| Arm 6 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 1 Participants |
| Arm 6 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 4 Participants |
| Arm 6 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 5 Participants |
| Arm 7 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 5 | 6 Participants |
| Arm 7 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 2-4 | 4 Participants |
| Arm 7 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | MOAA/S Score 0-1 | 0 Participants |
Secondary
Blood Concentrations of Propofol
Blood concentration of ICI35,868 (propofol)
Time frame: At the end of the initiation period and every 2 minutes during the maintenance period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 2 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | End of initiation period | 0.2208 µg/mL | Standard Deviation 0.1409 |
| Arm 2 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 2 minutes into maintenance period | 0.2797 µg/mL | Standard Deviation 0.132 |
| Arm 2 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 4 minutes into maintenance period | 0.3295 µg/mL | Standard Deviation 0.1474 |
| Arm 2 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 6 minutes into maintenance period | 0.3633 µg/mL | Standard Deviation 0.234 |
| Arm 3 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 4 minutes into maintenance period | 0.7387 µg/mL | Standard Deviation 0.3 |
| Arm 3 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 2 minutes into maintenance period | 0.6403 µg/mL | Standard Deviation 0.3087 |
| Arm 3 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | End of initiation period | 0.7808 µg/mL | Standard Deviation 0.3765 |
| Arm 3 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 6 minutes into maintenance period | 0.8127 µg/mL | Standard Deviation 0.2716 |
| Arm 4 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 6 minutes into maintenance period | 1.4263 µg/mL | Standard Deviation 0.67 |
| Arm 4 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 4 minutes into maintenance period | 1.2022 µg/mL | Standard Deviation 0.5612 |
| Arm 4 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 2 minutes into maintenance period | 1.1052 µg/mL | Standard Deviation 0.7197 |
| Arm 4 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | End of initiation period | 1.5033 µg/mL | Standard Deviation 0.9468 |
| Arm 5 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | End of initiation period | 2.3177 µg/mL | Standard Deviation 1.2459 |
| Arm 5 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 6 minutes into maintenance period | 2.4714 µg/mL | Standard Deviation 0.3901 |
| Arm 5 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 2 minutes into maintenance period | 2.1827 µg/mL | Standard Deviation 0.7832 |
| Arm 5 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 4 minutes into maintenance period | 2.4360 µg/mL | Standard Deviation 0.85 |
| Arm 6 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 4 minutes into maintenance period | 1.4828 µg/mL | Standard Deviation 0.4286 |
| Arm 6 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 6 minutes into maintenance period | 1.4848 µg/mL | Standard Deviation 0.4056 |
| Arm 6 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 2 minutes into maintenance period | 1.3965 µg/mL | Standard Deviation 0.7796 |
| Arm 6 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | End of initiation period | 1.1935 µg/mL | Standard Deviation 1.0758 |
| Arm 7 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 2 minutes into maintenance period | 0.8515 µg/mL | Standard Deviation 0.6399 |
| Arm 7 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 4 minutes into maintenance period | 1.0708 µg/mL | Standard Deviation 0.7864 |
| Arm 7 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | 6 minutes into maintenance period | 1.0560 µg/mL | Standard Deviation 0.7915 |
| Arm 7 - ICI35,868 (Propofol) | Blood Concentrations of Propofol | End of initiation period | 1.0875 µg/mL | Standard Deviation 0.7553 |
Secondary
Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Time frame: Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Placebo | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 5 | 20 Participants |
| Arm 1 - Placebo | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 2-4 | 0 Participants |
| Arm 1 - Placebo | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 2 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 2-4 | 2 Participants |
| Arm 2 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 2 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 5 | 18 Participants |
| Arm 3 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 5 | 20 Participants |
| Arm 3 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 3 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 2-4 | 0 Participants |
| Arm 4 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 2-4 | 4 Participants |
| Arm 4 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 4 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 5 | 16 Participants |
| Arm 5 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 2-4 | 9 Participants |
| Arm 5 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 0-1 | 1 Participants |
| Arm 5 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 5 | 10 Participants |
| Arm 6 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 0-1 | 0 Participants |
| Arm 6 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 5 | 10 Participants |
| Arm 6 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 2-4 | 0 Participants |
| Arm 7 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 5 | 9 Participants |
| Arm 7 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 2-4 | 1 Participants |
| Arm 7 - ICI35,868 (Propofol) | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | MOAA/S Score 0-1 | 0 Participants |
Secondary
Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire
The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied).
Time frame: 24 - 48 hours after completion of the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Placebo | Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | 62.5 Units on a scale | Standard Deviation 21.2 |
| Arm 2 - ICI35,868 (Propofol) | Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | 64.4 Units on a scale | Standard Deviation 23.8 |
| Arm 3 - ICI35,868 (Propofol) | Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | 74.5 Units on a scale | Standard Deviation 17.1 |
| Arm 4 - ICI35,868 (Propofol) | Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | 82.3 Units on a scale | Standard Deviation 17.9 |
| Arm 5 - ICI35,868 (Propofol) | Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | 86.0 Units on a scale | Standard Deviation 9.8 |
| Arm 6 - ICI35,868 (Propofol) | Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | 74.9 Units on a scale | Standard Deviation 16.2 |
| Arm 7 - ICI35,868 (Propofol) | Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | 75.1 Units on a scale | Standard Deviation 21.2 |