MedDataX Logo

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

NCT ID: NCT01189604

Last Updated: 2011-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Endoscopy Gastrointestinal Polypectomy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

propofol endoscopy sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm1 - Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Infusion of placebo, same infusion rates as for arm 2

Arm 2 - ICI35,868 (propofol)

Group Type ACTIVE_COMPARATOR

ICI35,868 (propofol)

Intervention Type DRUG

Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute

Arm 3 - ICI35,868 (propofol)

Group Type ACTIVE_COMPARATOR

ICI35,868 (propofol)

Intervention Type DRUG

Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute

Arm 4 - ICI35,868 (propofol)

Group Type ACTIVE_COMPARATOR

ICI35,868 (propofol)

Intervention Type DRUG

Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute

Arm 5 - ICI35,868 (propofol)

Group Type ACTIVE_COMPARATOR

ICI35,868 (propofol)

Intervention Type DRUG

Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute

Arm 6 - ICI35,868 (propofol)

Group Type ACTIVE_COMPARATOR

ICI35,868 (propofol)

Intervention Type DRUG

Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute

Arm 7 - ICI35,868 (propofol)

Group Type ACTIVE_COMPARATOR

ICI35,868 (propofol)

Intervention Type DRUG

Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Infusion of placebo, same infusion rates as for arm 2

Intervention Type DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute

Intervention Type DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute

Intervention Type DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute

Intervention Type DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute

Intervention Type DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute

Intervention Type DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johnson & Johnson K.K. Medical Company

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Masataka Date, M.D., Ph.D.

Role: STUDY_DIRECTOR

Physician Group, Clinical Division, R&D, Astrazeneca K.K.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Isesaki, Gunma, Japan

Site Status

Research Site

Moriya, Ibaragi, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D0092C00001

Identifier Type: -

Identifier Source: org_study_id