Clinical Study to Investigate the Efficacy and the Safety of DA-9501 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: November 2, 2015
Last verified: November 2015
  Purpose
The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care.

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 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:
  • Incidence of patients who did not require rescue administration of propofol to achieve and maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 during the study drug administration. [ Time Frame: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Administration frequency and dosage of propofol required to achieve and maintain OAA/S score ≤4 during the study drug administration [ Time Frame: 15 minutes after the start of study drug, if the OAA/S score is 5. ] [ Designated as safety issue: No ]
    If the OAA/S score is 5, 0.2 mg/kg of propofol as a sedative is administered intravenously by slow "IV push" and the administration is to be repeated until the target level of sedation (OAA/S score ≤4) is achieved.

  • Time to first rescue administration of propofol [ Time Frame: During the study drug infusion period (≥15 minutes [Approximate]) ] [ Designated as safety issue: No ]
  • Incidence of patients who did not require rescue administration of fentanyl during the study drug administration [ Time Frame: After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes. ] [ Designated as safety issue: No ]
  • Percentage of time spent OAA/S Score ≤4 during the study drug infusion [ Time Frame: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative. ] [ Designated as safety issue: No ]
  • Percentage of time spent OAA/S Score 3 to 4 during the study drug infusion [ Time Frame: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative. ] [ Designated as safety issue: No ]
  • Time to attain the point where patient is recovered assessed by Aldrete score following discontinuation of the study drug infusion [ Time Frame: Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8. ] [ Designated as safety issue: No ]
  • Visual Analogue Scale (VAS) score evaluation by Investigator or sub-investigator (ease of maintaining sedation level, hemodynamic stability, respiratory stability, subject's cooperativeness) [ Time Frame: Within 24 hours after completion of the study drug administration ] [ Designated as safety issue: No ]
  • Score evaluation of satisfaction and anxiety of the subject [ Time Frame: Within 24 hours after completion of the study drug administration (as much as possible) ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Dexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose
Drug: Placebo
Experimental: Dexmedetomidine 0.067 mcg/kg
Dexmedetomidine 0.4 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
Experimental: Dexmedetomidine 0.25 mcg/kg
Dexmedetomidine 1.5 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
Experimental: Dexmedetomidine 0.5 mcg/kg
Dexmedetomidine 3 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
Experimental: Dexmedetomidine 1.0 mcg/kg
Dexmedetomidine 6 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose
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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has signed and dated the Informed Consent after the study had been fully explained.
  2. Patient is male or female, at least 20 years of age when the Informed Consent is obtained.
  3. American Society for Anesthesiologists (ASA) I to III Class.
  4. Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.
  5. Patient undergoing a surgery requiring epidural or spinal anesthesia

Exclusion Criteria:

  1. Patient who underwent general anesthesia within 7 days, or who received other study drugs within 30 days from the date of consent.
  2. Patient with <92% SpO2, at the physical examination prior to the study drug administration, or ventilatory failure which requires intubation or Laryngeal Mask.
  3. Patient with central nervous system pathology which may lead to increased intracranial pressure, uncontrolled seizures, psychiatric disorder which may be confused with the response to sedation treatment.
  4. Patient who require general anesthesia.
  5. Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
  6. Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.
  7. Patient diagnosed with unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
  8. Patient whose heart rate is <60 bpm, systolic blood pressure is <90 mmHg by the physical examination prior to the study drug administration.
  9. Patient has third degree heart block, unless the patient has a pacemaker or transverse pacing wires are in place.
  10. Patient who has experienced an increase in alanine transaminase (ALT) and / or aspartate aminotransferase (AST) more than double the upper normal limit within 2 months of the date of consent, or who has a history of liver insufficiency.
  11. Pregnant or lactating woman.
  12. In the Investigator's or subinvestigator's opinion, the patient has any symptom or condition which might increase risk to the patient by conducting the study or preclude obtaining satisfactory study data
  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 University Hospital
Nagoya, Aichi, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kochi Medical School Hospital
Nangoku, Kochi, Japan
Shinshul University Hospital
Matsumoto, Nagano, Japan
Shimane University Hospital
Izumo, Shimane, Japan
Tottori University Hospital
Yonago, Tottori, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Japan
University of Miyazaki Hospital
Miyazaki, Japan
Okayama University Hospital
Okayama, Japan
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Osaka, Japan
Nippon Medical University Hospital
Tokyo, Japan
Sponsors and Collaborators
Hospira, Inc.
Maruishi Pharmaceutical
  More Information

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: November 2, 2015
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
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 August 25, 2016