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

ClinicalTrials.gov processed this record on April 14, 2014