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

• ClinicalTrials.gov Identifier: NCT01189604
• Recruitment Status: Completed
• First Posted: August 26, 2010
• Results First Posted: December 13, 2011
• Last Update Posted: December 19, 2011
• Sponsor: AstraZeneca
• Collaborator: Johnson & Johnson K.K. Medical Company
• Information provided by (Responsible Party): AstraZeneca

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Endoscopy; Gastrointestinal Polypectomy	Drug: Placebo; Drug: ICI35,868 (propofol)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: August 2010
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: November 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period [ Time Frame: 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.
2. Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period [ Time Frame: 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 :

1. Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire [ Time Frame: 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).
2. Blood Concentrations of Propofol [ Time Frame: At the end of the initiation period and every 2 minutes during the maintenance period ]
   Blood concentration of ICI35,868 (propofol)
3. Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Japan

Research Site

Isesaki, Gunma, Japan

Research Site

Moriya, Ibaragi, Japan

Sponsors and Collaborators

AstraZeneca

Johnson & Johnson K.K. Medical Company

Investigators

• Study Director: Masataka Date, M.D., Ph.D.; Physician Group, Clinical Division, R&D, Astrazeneca K.K.

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01189604
• Other Study ID Numbers: D0092C00001
• First Posted: August 26, 2010
• Results First Posted: December 13, 2011
• Last Update Posted: December 19, 2011
• Last Verified: December 2011

Keywords provided by AstraZeneca:

propofol endoscopy sedation

Additional relevant MeSH terms:

Propofol; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics