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

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ClinicalTrials.gov Identifier: NCT00209573
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 7, 2008
Sponsor:
Collaborators:
PPD
Bio Analytical Research Corporation
MDS Pharma Services
Coghlan Group (Plasma Sample Supplies)
Information provided by:
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Colon Polyps Drug: fospropofol disodium Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-Label Study to Assess the Safety and Efficacy of AQUAVAN Injection Versus Midazolam HCl for Sedation in Patients Undergoing Colonoscopy Procedures
Study Start Date : September 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Midazolam
U.S. FDA Resources




Primary Outcome Measures :
  1. The primary efficacy hypothesis was that AQUAVAN could sedate (≥3 consecutive Modified OAA/S scores ≤4) patients AND that they could complete the procedure successfully without requiring alternative sedative medication AND without requiring manual or

Secondary Outcome Measures :
  1. Secondary Efficacy Endpoints
  2. Time to Fully Recovered from end of procedure
  3. Time to Fully Alert from end of procedure
  4. Change from baseline DSST score over time during recovery period
  5. Duration and percent of time when a patient's Modified OAA/S score is at each level between the first dose of study medications and Fully Alert, inclusive
  6. Duration of sedation
  7. Number of doses of study medication administered for the procedure
  8. Time to sedation
  9. Time to reach splenic flexure, hepatic flexure, cecum, and end of procedure
  10. Number of repositionings
  11. Number of procedure interruptions due to inadequate sedation
  12. Patient's rating of experience after Fully Recovered
  13. Patient's rating at 24 hour post discharge telephone survey
  14. Investigator's rating at end of procedure
  15. Blinded evaluator's rating after patient is Fully Recovered
  16. Safety Endpoints
  17. Nature, frequency, severity, relationship to treatment, and outcome of all adverse events
  18. Airway assistance
  19. Sedation-related adverse events
  20. Laboratory parameters and vital signs
  21. Concomitant medications


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209573


Sponsors and Collaborators
Eisai Inc.
PPD
Bio Analytical Research Corporation
MDS Pharma Services
Coghlan Group (Plasma Sample Supplies)
Investigators
Study Director: James Jones, MD,PharmD Eisai Inc.

ClinicalTrials.gov Identifier: NCT00209573     History of Changes
Other Study ID Numbers: 3000-0410
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 7, 2008
Last Verified: November 2008

Keywords provided by Eisai Inc.:
Colonoscopy
Sedation

Additional relevant MeSH terms:
Midazolam
Fospropofol
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action