Clinical Study to Investigate the Efficacy and the Safety of Dexmedetomidine in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation

This study has been completed.
Sponsor:
Collaborator:
Maruishi Pharmaceutical
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01438957
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 surgery with epidural anesthesia or spinal anesthesia without intubation


Condition Intervention Phase
Sedation
Drug: Dexmedetomidine hydrochloride
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 With Epidural Anesthesia or Spinal Anesthesia 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 [ 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 (OAA/S) [ Time Frame: Every 5 minutes ] [ Designated as safety issue: No ]
    Administration frequency and dosage of rescue sedative requried to achieve and maintain adequate sedation level during the study drug adminstration.

  • Direct communication with the subject [ Time Frame: Continuously ] [ Designated as safety issue: No ]
    Incidence of patients who did not require rescue analgesia durign teh 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: 120
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: P Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
Active Comparator: Dexmedetomidine 0.067 ug/kg Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
Active Comparator: Dexmedetomidine 0.25 ug/kg Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
Active Comparator: Dexmedetomidine 0.5 ug/kg Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
Active Comparator: Dexmedetomidine 1.0 ug/kg Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

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 with spinal or epidural anesthesia 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 which requires ≥30mins (expected time) without intubation.
  • ASA I to III Class.
  • Patient undergoing a surgery requiring epidural or spinal anesthesia

Exclusion Criteria:

  • 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: NCT01438957

Locations
Japan
Nagoya-City, Aichi, Japan
Asahikawa-City, Hokkaido, Japan
Sapporo-City, Hokkaido, Japan
Nangoku-City, Kochi, Japan
Kyoto-City, Kyoto, Japan
Miyazaki-City, Miyazaki, Japan
Matsumoto-City, Nagano, Japan
Okayama-City, Okayama, Japan
Osaka-City, Osaka, Japan
Izumo-City, Shimane, Japan
Bunkyo-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: NCT01438957     History of Changes
Other Study ID Numbers: DEX-303
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
epidural anesthesia
spinal anesthesia

Additional relevant MeSH terms:
Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
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 September 18, 2014