NCT00209586

TerminatedPhase 3

A Study of AQUAVAN® Injection for Sedation in Elderly Patien...

Eisai Inc.Source

Eisai Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

3000-0409

Study Type

interventional

Actual enrollment (reported)

55

Locations

0 countries

Sites

N/A

Timeline

Study Start

September 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2005

Actual (reported)

Study Completion

March 2005

Actual (reported)

Brief Summary

This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing flexible bronchoscopy as well as to assess the safety profile of AQUAVAN versus that of midazolam. Prior to the procedure, patients receive fentanyl citrate for pain management followed five minutes later by either AQUAVAN® Injection or midazolam HCl for sedation. During the procedure, study personnel assess the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator are asked to complete satisfaction surveys.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 55 participants
Study completion date: March 2005
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2004
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2005
Actual (reported)
Study Completion
March 2005
Actual (reported)
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)

Last Updated: June 15, 2023
Status Verified: January 2012
Last Update Submitted: June 14, 2023

Conditions

Flexible Bronchoscopy

Keywords

BronchoscopySedation

Outcome Measures

Primary Outcomes (1)

Sedation success defined for a patient as having 3 consecutive Modified OAA/S scores <=4 and completing the procedure without requiring alternative sedative medications and without requiring manual or mechanical ventilation.

Secondary Outcomes (20)

Secondary Efficacy Endpoints
Time to Fully Recovered from end of procedure
Time to Fully Alert from end of procedure
Change from baseline DSST score over time during recovery period
Modified OAA/S scores over time during the dosing initiation, procedural, and recovery periods
+15 more secondary outcomes

Interventions

fospropofol disodiumDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient provided signed/dated Informed Consent and HIPAA Authorization after receiving a full explanation of the extent and nature of the study.
Patient was at least 18 years of age at the time of screening.

Sponsors & Collaborators

Covance
Industrycollaborator
Quest Pharmaceutical Services
Industrycollaborator
Eisai Inc.

MeSH Terms

Interventions

fospropofol

Study Officials

James Jones, MD, PharmD
Eisai Inc.
STUDY DIRECTOR

Enrollment

55 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 2004

Date type not reported

This date has not been verified as actual or estimated.

NCT00209534

A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy

Phase 2Completed

NCT00789815

Bispectral Index-guided Sedation for Flexible Bronchoscopy

Phase 4Completed

NCT01101477

Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation

Not ApplicableTerminated

NCT05340907

Patient Satisfaction and Tolerability Using Virtual Reality (VR) as Adjunctive Treatment During Flexible Bronchoscopy

Not ApplicableCompleted

NCT02262442

Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer During the Bronchoscopy

Phase 4Unknown

NCT07333508

Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation

Phase 4Not Yet Recruiting

Female patient must have been surgically sterile, postmenopausal, or not pregnant or lactating, and must have been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and predosing periods.

Patient met the American Society of Anesthesiologists (ASA) Physical Status Classification of I to III.

You may not qualify if:

Patient had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic or benzodiazepine.
Patient did not meet nils per os (NPO) status per ASA Guideline or institution's guideline.
Patient had condition(s) that, in the opinion of the Investigator, could interfere with appropriate airway management.
Patient required artificial ventilation prior to the initiation of bronchoscopy or was admitted to the intensive care unit.
Patient had a history of mental or visual impairment that would not permit successful measurement of cognitive evaluations.
Patient was unwilling to adhere to pre- and postprocedural instructions.
The use of fentanyl or midazolam was contraindicated for the patient.
Patient had participated in an investigational study within 1 month prior to study start.

Contact the study team to confirm eligibility.

Industrylead

PPD Development, LP

Industrycollaborator

Primary Completion

March 2005

Actual (reported)

Study Completion

March 2005

Actual (reported)

Last Updated

June 15, 2023

Record last verified: 2012-01

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00209586
Data provider: ClinicalTrials.gov
Source updated: 2023-06-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:47 UTC

Study Stopped

A Study of AQUAVAN® Injection for Sedation in Elderly Patients Undergoing Flexible Bronchoscopy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record