- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00209599
A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Elderly Patients Undergoing Elective Colonoscopy
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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.
|
Secondary Outcome Measures
Outcome Measure |
---|
Duration of sedation
|
Number of doses of study medication administered for the procedure
|
Time to sedation
|
Number of repositionings
|
Measures of recovery and cognitive functions by the blinded evaluator
|
Time to Fully Recovered from the end of the procedure
|
Time to Fully Alert from the end of the procedure
|
Change from baseline DSST score over time during the Recovery period
|
Measures of sedation adequacy
|
Modified OAA/S scores over time during the Dosing Initiation, Procedural, and Recovery periods
|
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
|
Time that splenic flexure, hepatic flexure, and cecum are reached, and time to end of procedure
|
·Number of procedure interruptions due to inadequate sedation
|
Patient-reported outcome and Investigator's assessment
|
Patient's rating of experience after Fully Recovered (including patient's level of sedation, memory recall, pain/discomfort, and willingness to be treated again);
|
Patient's rating at 24-hour telephone survey (including time to normal food intake and time to resuming normal activities)
|
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)
|
Blinded evaluator's rating after Fully Recovered
|
Safety Variables
|
The following were safety endpoints:
|
Nature, frequency, severity, relationship to treatment, and outcome of all treatment emergent AEs (TEAEs)
|
Airway management (manual repositioning, increased oxygen flow, verbal or tactile stimulation)
|
Airway intervention (suction, manual ventilation, endotracheal intubation or other mechanical airway management)
|
Sedation-related AEs (hypopnea, apnea, hypoxemia, bradycardia, hypotension,)
|
Alternative sedation/hypnotic medications
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: James Jones, MD,PharmD, Eisai Inc.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3000-0415
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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