Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-centre, Single-blind, Randomised, Parallel Group, Phase IIb Dose Rate Range Finding Study to Find Maintenance Dose Rate Range of ICI35,868 for the Minimal-to-moderate Sedation on Gastrointestinal Endoscopic Tests (Including Endoscopic Polypectomy)

Conditions
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Gastrointestinal Endoscopy, Gastrointestinal Polypectomy

Intervention / Treatment
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* Drug: Placebo
* Drug: ICI35,868 (propofol)
* Drug: ICI35,868 (propofol)
* Drug: ICI35,868 (propofol)
* Drug: ICI35,868 (propofol)
* Drug: ICI35,868 (propofol)
* Drug: ICI35,868 (propofol)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm1 - Placebo<br> | Drug: Placebo<br>* Infusion of placebo, same infusion rates as for arm 2<br>|
| Active Comparator: Arm 2 - ICI35,868 (propofol)<br> | Drug: ICI35,868 (propofol)<br>* Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute<br>|
| Active Comparator: Arm 3 - ICI35,868 (propofol)<br> | Drug: ICI35,868 (propofol)<br>* Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute<br>|
| Active Comparator: Arm 4 - ICI35,868 (propofol)<br> | Drug: ICI35,868 (propofol)<br>* Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute<br>|
| Active Comparator: Arm 5 - ICI35,868 (propofol)<br> | Drug: ICI35,868 (propofol)<br>* Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute<br>|
| Active Comparator: Arm 6 - ICI35,868 (propofol)<br> | Drug: ICI35,868 (propofol)<br>* Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute<br>|
| Active Comparator: Arm 7 - ICI35,868 (propofol)<br> | Drug: ICI35,868 (propofol)<br>* Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 minutes from the beginning of the maintenance period | 
| 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. | 4 minutes from the beginning of the maintenance period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 - 48 hours after completion of the procedure | 
| Blood Concentrations of Propofol | Blood concentration of ICI35,868 (propofol) | At the end of the initiation period and every 2 minutes during the maintenance period | 
| 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. | Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol endoscopy sedation