Colonoscopy Clinical Trial
Official title:
A Randomized, Double-Blind, Dose-Response Study to Assess the Efficacy and Safety of AQUAVAN® Injection for Procedural Sedation in Patients Undergoing Colonoscopy
Very often, patients receive sedative medication before a diagnostic, therapeutic, or
surgical procedure to help them relax, keep them calm, and to relieve them from pain. This
is called procedural sedation. During procedural (mild to moderate) sedation, a patient is
first given a pain-relief medication (analgesic) and then a medication to help him/her relax
and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it
releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol
disodium) is made as a slow release version of propofol, allowing for fast sedation and
possibly faster recovery and discharge.
This study is intended to compare several different doses of AQUAVAN in patients having a
colonoscopy in order to find the right dose that will get patients to a level of mild to
moderate (procedural) sedation.
This is a randomized, double-blind study designed to evaluate the dose-response in the
sedation success rate for 4 different initial bolus doses of AQUAVAN following pretreatment
with an analgesic, fentanyl, in patients undergoing a colonoscopy. A group of patients will
receive midazolam as a reference therapy.
Following completion of pre-procedure assessments, patients will be randomly assigned to 1
of 5 IV treatment groups at an equal allocation ratio (25 patients per arm) on the day of
the scheduled procedure. Randomization will be stratified by age and ASA status:
AQUAVAN initial bolus dose 1: 8 mg/kg AQUAVAN initial bolus dose 2: 6.5 mg/kg AQUAVAN
initial bolus dose 3: 5 mg/kg AQUAVAN initial bolus dose 4: 2 mg/kg Midazolam initial bolus
dose: 0.02 mg/kg
A person skilled in airway management and authorized by the facility in which the
colonoscopy is performed (such as a respiratory therapist, a study nurse, or a clinician)
must be immediately available during the conduct of the study. All patients will be placed
on supplemental oxygen via nasal cannula (4 L/min), and a 12-lead electrocardiogram (ECG),
pulse oximeter, and blood pressure monitor prior to administration of study medication. All
patients will receive an injection of analgesic pretreatment followed by the administration
of sedative medication, as described below. This protocol recognizes 2 distinct phases of
sedation: Sedation Initiation and Sedation Maintenance. Assessments will be made to evaluate
the patients for levels of sedation, clinical benefit, and adverse events as detailed in the
protocol. Blood samples will be collected for pharmacokinetic (PK) analysis, also detailed
in the protocol.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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