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

Randomized, open label, multi-center, adaptive dose ranging study, in which several dose levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to produce a desired sedation level in patients undergoing elective colonoscopy. A desired sedative dose/dose range and dosing paradigm will be identified based on pre-set criteria using the Modified Observer's Assessment of Alertness/Sedation (OAA/S). The desired sedative dose/dose range and dosing paradigm of AQUAVAN® Injection is defined as one that consistently provides mild to moderate sedation (Modified OAA/S between 2 and 4 inclusive) in a majority of patients who are pre-medicated with fentanyl citrate injection.

Inclusion criteria

• Patients provided written informed consent after receiving a full explanation of the extent and nature of the study.
• Patients were >=18 years of age to ≤60 years (a subset of up to 50 patients >60 years and <85 years of age was allowed).
• Patients, if female, were surgically sterile, postmenopausal or non-pregnant 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 predose.
• Body mass index (BMI) between 20 and 28.
• Body weight between 50 kg and 100 kg.
• Patients had an ASA Physical Classification System status of I or II;
• Patients required an elective colonoscopy procedure that was anticipated to be performed in <60 minutes (i.e., procedure was predicted to be uncomplicated); desired sedation for the colonoscopy procedure; and were determined by the Investigator to be physically capable of maintaining an adequate airway during mild-to-moderate sedation.

Exclusion criteria

• Patients ingested benzodiazepines or barbiturates within 14 days of study start, with the exception of phenobarbital, which required a 21-day washout.
• Patients ingested opioids within 72 hours of study start.
• Patients had current symptoms of upper respiratory infection.
• Patients had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
• Patients had current signs of significant hiatal hernia, esophageal reflux, or heartburn which, in the opinion of the Investigator, could interfere with maintenance of an adequate airway.
• Patients had a history of alcohol or drug abuse within the past 12 months;
• Patients ingested alcohol or caffeine within 12 hours prior to admission into the study.
• Patients participated in an investigational drug study within 1 month prior to study start.
• Patients were unwilling to adhere to preprocedural and postprocedural instructions.
• Patients donated >300 mL of blood within 1 month prior to study start; or
• Patients were exposed to AQUAVAN in a previous clinical trial.