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

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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:
Collaborator:
Johnson & Johnson K.K. Medical Company
Information provided by (Responsible Party):
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.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Propofol

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189604


Locations
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Japan
Research Site
Isesaki, Gunma, Japan
Research Site
Moriya, Ibaragi, Japan
Sponsors and Collaborators
AstraZeneca
Johnson & Johnson K.K. Medical Company
Investigators
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Study Director: Masataka Date, M.D., Ph.D. Physician Group, Clinical Division, R&D, Astrazeneca K.K.

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01189604    
Other Study ID Numbers: D0092C00001
First Posted: August 26, 2010    Key Record Dates
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:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics