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ColonoscopyPhase 2NCT00209599

A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Elderly Patients Undergoing Elective Colonoscopy

A Phase 2 study testing fospropofol disodium in people with Colonoscopy and Colon Polyps, run by Eisai Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in elderly patients undergoing colonoscopy as well as to assess the safety profile of AQUAVAN versus that of midazolam. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Colonoscopy, Colon Polyps
What is being tested?
fospropofol disodium
How many people
100 participants
Where
No sites listed yet
Study dates
Feb 2005to Mar 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patient provided a signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study.
  • Patient was over 65 years of age at the time of screening.
  • Patient met ASA Physical Status Classification of I to III.

Who cannot join

  • 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 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 drug study within 1 month prior to study start.
  • Patient had prior exposure to AQUAVAN.

About this study

Official title: A Phase II, Randomized, Open-Label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Elderly Patients Undergoing Colonoscopy Procedures

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

Read the detailed description

This is a randomized, open-label study designed to assess the safety and efficacy of AQUAVAN ® Injection versus midazolam HCl following pretreatment with an analgesic, fentanyl citrate injection, in producing sedation in elderly patients undergoing colonoscopy.

Following completion of preprocedure sedation assessments, patients will be randomly assigned to 1 of the 2 i.v. treatment groups at a 4:1 (AQUAVAN®. Injection: midazolam HCl) allocation ratio. To ensure that a distribution of ages is obtained, enrollment will be stratified into 2 equal-size groups by age (>65 to <72 years of age and >72 years of age). Randomization will be stratified by site within each age group. All patients will receive fentanyl citrate injection as an analgesic pretreatment. Supplemental doses of fentanyl citrate injection may be administered if the patient reports pain or if inadequate analgesia is present as demonstrated by increased heart rate and/or blood pressure in the presence of adequate sedation.

At no time should fentanyl citrate injection be administered to increase sedation levels.

AQUAVAN®. Injection and midazolam HCl will be administered to induce a state of adequate sedation, defined as a Modified Observer's Assessment of Alertness/Sedation (OAA/S) score of 4 or less. Supplemental doses will be administered to increase depth or duration of sedation. Supplemental doses will not be administered if the Modified OAA/S score is 2 or less or if there is no purposeful response to stimulation. The depth of sedation will be measured by the Modified OAA/S scale, a validated measure. Patient and Investigator assessments will be used to confirm the depth of sedation provided met the goals of sedation, reduction of anxiety and reduced awareness.

Being tested
fospropofol disodium
Keywords
Colonoscopy, Seadation
Medical subject headings
Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fospropofol disodiumDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy endpoint was Sedation Success defined as a patient 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 (25)

  1. Measures of recovery and cognitive functions by the blinded evaluator

  2. Time to Fully Recovered from the end of the procedure

  3. Time to Fully Alert from the end of the procedure

  4. Change from baseline DSST score over time during the Recovery period

  5. Measures of sedation adequacy

  6. Modified OAA/S scores over time during the Dosing Initiation, Procedural, and Recovery periods

  7. Duration and percent of time when a patient's Modified OAA/S score is at each level between the first dose of study medication and Fully Alert, inclusive

  8. Duration of sedation

  9. Number of doses of study medication administered for the procedure

  10. Time to sedation

  11. Time that splenic flexure, hepatic flexure, and cecum are reached, and time to end of procedure

  12. Number of repositionings

  13. ·Number of procedure interruptions due to inadequate sedation

  14. Patient-reported outcome and Investigator's assessment

  15. Patient's rating of experience after Fully Recovered (including patient's level of sedation, memory recall, pain/discomfort, and willingness to be treated again);

  16. Patient's rating at 24-hour telephone survey (including time to normal food intake and time to resuming normal activities)

  17. Investigator's rating at the end of the procedure (including patient's level of sedation, pain/discomfort, anxiety, response to instructions, overall satisfaction with the study drug, and willingness to be use sedatives again)

  18. Blinded evaluator's rating after Fully Recovered

  19. Safety Variables

  20. The following were safety endpoints:

  21. Nature, frequency, severity, relationship to treatment, and outcome of all treatment emergent AEs (TEAEs)

  22. Airway management (manual repositioning, increased oxygen flow, verbal or tactile stimulation)

  23. Airway intervention (suction, manual ventilation, endotracheal intubation or other mechanical airway management)

  24. Sedation-related AEs (hypopnea, apnea, hypoxemia, bradycardia, hypotension,)

  25. Alternative sedation/hypnotic medications

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Study completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00209599
Sponsor's protocol ID
3000-0415
Status last verified
Nov 2008
First submitted
13 Sep 2005
Last updated
18 Jun 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fospropofol disodium in people with Colonoscopy and Colon Polyps, run by Eisai Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy endpoint was Sedation Success defined as a patient having 3 consecutive Modified OAA/S scores ≤4 and completing the procedure without requiring alternative sedative medications and without requiring manual or mechanical ventilation.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00209599.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.

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