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

Phase 2

Completed

• Conditions: Gastrointestinal Endoscopy; Gastrointestinal Polypectomy
• Interventions: Drug: Placebo; Drug: ICI35,868 (propofol)

• Registration Number: NCT01189604
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2011-11-09
• Results First Submitted QC: 2011-11-09
• Status Verified: 2011-12
• Results First Posted: 2011-12-13
• Last Update Submitted: 2011-12-15
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm1 - Placebo	Placebo	-
Arm 2 - ICI35,868 (propofol)	ICI35,868 (propofol)	-
Arm 4 - ICI35,868 (propofol)	ICI35,868 (propofol)	-
Arm 5 - ICI35,868 (propofol)	ICI35,868 (propofol)	-
Arm 6 - ICI35,868 (propofol)	ICI35,868 (propofol)	-
Arm 3 - ICI35,868 (propofol)	ICI35,868 (propofol)	-
Arm 7 - ICI35,868 (propofol)	ICI35,868 (propofol)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Moriya, Ibaragi, Japan