NCT00125424

Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy

A Randomized, Double-Blind, Dose-Response Study to Assess the Efficacy and Safety of AQUAVAN® Injection for Procedural Sedation in Patients Undergoing Colonoscopy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 125 (planned)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colonoscopy
• Colonic Polyps

Interventions

Type	Name	Description
DRUG	AQUAVAN® (fospropofol disodium) Injection
DRUG	Midazolam HCl

Timeline

• Start date: 2005-07-01
• Completion: 2005-09-01
• First posted: 2005-08-01
• Last updated: 2008-11-07

Locations

20 sites across 1 country: United States