Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Study to Investigate the Efficacy and the Safety of Dexmedetomidine in Sedation During the Surgery or Medical Procedure Without Intubation

This study has been completed.
Sponsor:
Collaborator:
Maruishi Pharmaceutical
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01438931
First received: September 21, 2011
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

Evaluate the efficacy and the safety of Dexmedetomidine in sedation during the surgery or medical procedure without intubation


Condition Intervention Phase
Sedation
Drug: Dexmedetomidine hydrochloride
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation Under Monitored Sedation Care

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Observer's Assessment of Alertness/Sedation Score (OAA/S) [ Time Frame: Every 5 minutes ] [ Designated as safety issue: No ]
    Incidence of patients who did not require rescue sedative to achieve and maintain adequate sedation level during the study drug administration


Secondary Outcome Measures:
  • Observer's Assessment of Alertness/Sedation Score [ Time Frame: Every 5 minutes ] [ Designated as safety issue: No ]
    Administration frequency and dosage of rescue sedative required to achieve and maintain adequate sedation level during the study drug administration

  • Direct communication with the subject [ Time Frame: Continuously ] [ Designated as safety issue: No ]
    Incidence of patients who did not require rescue analgesia during the study drug administration

  • Clinical symptoms [ Time Frame: Continuously ] [ Designated as safety issue: No ]
    Administration frequency and dosage of rescue analgesia during the study drug administration


Enrollment: 162
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Loading infusion of Placebo over 10 minutes followed by maintenance infusion of Placebo
Drug: placebo
Dexmedetomidine hydrochloride Variable dose
Active Comparator: 0.5
Loading infusion of either Dexmedetomidine 3.0 mcg/kg/hr, over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.2
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine hydrochloride variable dose
Active Comparator: 1.0
Loading infusion of either Dexmedetomidine 6.0 mcg/kg/hr, over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.7mcg/kg/hr
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine hydrochloride variable dose

Detailed Description:

Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery or medical procedure under monitored sedation care

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who requires sedation during the elective surgery or procedure which requires ≥30mins (expected time) without intubation.
  • ASA I to III Class.
  • Patient who requires local or regional anesthesia

Exclusion Criteria:

  • Patient who requires epidural anesthesia or spinal anesthesia for the surgery or procedure.
  • Patient diagnosed unstable angina or acute myocardiac infarction within past 6 weeks.
  • Patient whose heart rate less than 50 bpm, systolic blood pressure less than 90 mmHg.
  • Patient has third degree heart block
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438931

Locations
Japan
Asahikawa-City, Hokkaido, Japan
Amagasaki-City, Hyogo, Japan
Tsukuba-City, Ibaragi, Japan
Kagoshima-City, Kagoshima, Japan
Kyoto-City, Kyoto, Japan
Miyazaki-City, Miyazaki, Japan
Okayama-City, Okayama, Japan
Toyomijo-City, Okinawa, Japan
Hirakata-City, Osaka, Japan
Osaka-City, Osaka, Japan
Suita-City, Osaka, Japan
Hidaka-City, Saitama, Japan
Izumo-City, Shimane, Japan
Shinjuku-ku, Tokyo, Japan
Yonago-City, Tottori, Japan
Sponsors and Collaborators
Hospira, Inc.
Maruishi Pharmaceutical
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01438931     History of Changes
Other Study ID Numbers: DEX-301
Study First Received: September 21, 2011
Last Updated: May 23, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Hospira, Inc.:
Dexmedetomidine
Sedation
Non-intubation
local anesthesia

Additional relevant MeSH terms:
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014