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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Dose rate range finding study of propofol for minimal-to moderate sedation on upper & lower endoscopic tests

Infusion of placebo, same infusion rates as for arm 2

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

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

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

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

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

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

Research Site

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)

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.

Age Continuous

Gender, Male/Female

Patients underwent either esophagogastroduodenoscopy (EGD) or colonoscopy.

Procedures

Study Specific Characteristic

MOAA/S Score 0-1

MOAA/S Score 2-4

MOAA/S Score 5

Modified Observers Assessment of Alertness/Sedation (MOAA/S) score 2 minutes from beginning of maintenance period

Modified Observers Assessment of Alertness/Sedation (MOAA/S) score 4 minutes from beginning of maintenance period

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).

Patient Satisfaction with Sedation Instrument (PSSI) questionnaire

End of initiation period

2 minutes into maintenance period

4 minutes into maintenance period

6 minutes into maintenance period

Blood concentration of ICI35,868 (propofol)

Blood concentrations of propofol

Modified Observers Assessment of Alertness/Sedation (MOAA/S) at end of initiation period

Overall Study

The patients enrolled in this study were undergoing non-emergent standard esophagogastroduodenoscopy (EGD) or colonoscopy. Six patients were withdrawn from the study after enrollment but before randomization: 5 patients due to excess recruitment and one patient due to investigator's recommendation..

Arms	Assigned Interventions
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

Dose rate range finding study of propofol for minimal-to moderate sedation on upper & lower endoscopic tests

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=226&filename=CSR-D0092C00001.pdf

CSR-D0092C00001.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator