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

Gastrointestinal Endoscopy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189604
• Other study ID #: D0092C00001
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2010
• Last updated: December 15, 2011
• Start date: August 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Endoscopy
• Gastrointestinal Polypectomy

Intervention

Drug:
• Placebo
Infusion of placebo, same infusion rates as for 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
• ICI35,868 (propofol)
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
• ICI35,868 (propofol)
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
• ICI35,868 (propofol)
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
• ICI35,868 (propofol)
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
• ICI35,868 (propofol)
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute

Locations

Country	Name	City	State
Japan	Research Site	Isesaki	Gunma
Japan	Research Site	Moriya	Ibaragi

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Johnson & Johnson K.K. Medical Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 minutes from the beginning of the maintenance period	No
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.	4 minutes from the beginning of the maintenance period	No
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).	24 - 48 hours after completion of the procedure	No
Secondary	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	No
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.	Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)	No