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

NCT ID: NCT00209573

Last Updated: 2008-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2004-12-31

Brief Summary

This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in 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.

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 patients undergoing colonoscopy. Randomization will be stratified by site. Following completion of pre-procedure sedation assessments, patients will be randomly assigned to 1 of the 2 i.v. treatment groups at a 3:1 (AQUAVAN® Injection: midazolam HCl) allocation ratio. All study patients, irrespective of treatment group assignment, 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 anxiet, and reduced awareness.

Conditions

Colonoscopy; Colon Polyps

Keywords

Colonoscopy; Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

fospropofol disodium

Intervention Type: DRUG

Eligibility Criteria

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, if female, were surgically sterile, postmenopausal or non-pregnant and non lactating 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 periods; and
• Patient met American Society of Anesthesiologists (ASA) Physical Status Classification System 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 participated in an investigational drug study within 1 month prior to study start;
• 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; or
• Patient for whom the use of fentanyl or midazolam was contraindicated.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Bio Analytical Research Corporation

INDUSTRY

Sponsor Role: collaborator

MDS Pharma Services

INDUSTRY

Sponsor Role: collaborator

Coghlan Group (Plasma Sample Supplies)

UNKNOWN

Sponsor Role: collaborator

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

James Jones, MD,PharmD

Role: STUDY_DIRECTOR

Eisai Inc.

Other Identifiers

3000-0410

Identifier Type: -

Identifier Source: org_study_id