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Completed

NCT Number: NCT01189604

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

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.

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Key information

Conditions

Gastrointestinal Endoscopy Gastrointestinal Polypectomy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Isesaki, Gunma, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Infusion of placebo, same infusion rates as for arm 2

ICI35,868 (propofol)

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Johnson & Johnson K.K. Medical Company

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 26, 2010
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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