Clinical Study to Investigate the Efficacy and the Safety of DA-9501 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: July 23, 2015
Last verified: July 2015
  Purpose
The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation under monitored sedation care.

Condition Intervention Phase
Sedation
Drug: DA-9501
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 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:
  • 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 during 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: After the start of study drug (20 ± 2 minutes), 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: ≥15 minutes after the start of study drug infusion. ] [ 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 ]
  • Administration frequency and dosage of fentanyl required 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 during 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 during 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 an Aldrete score ≥9 following discontinuation of the study drug infusion [ Time Frame: Every 15 ± 2 minutes until the total score value becomes ≥9. ] [ 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: 162
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo group
Loading infusion of Placebo over 10 minutes followed by maintenance infusion of Placebo
Drug: placebo
Active Comparator: DA-9501 0.5 mcg/kg group
Loading infusion of Dexmedetomidine 3.0 mcg/kg/hr over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.2-0.7 mcg/kg/hr
Drug: DA-9501
Dexmedetomidine hydrochloride variable dose
Active Comparator: DA-9501 1.0 mcg/kg group
Loading infusion of Dexmedetomidine 6.0 mcg/kg/hr over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.2-0.7 mcg/kg/hr
Drug: DA-9501
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   (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 at the preoperative diagnosis.
  4. New York Heart Association (NYHA) classification is I to III (Only patients who need classification of cardiac performance.)
  5. Patient who requires sedation during the following elective surgery or procedure which require ≥30mins (expected time) without intubation under monitored sedation care.

    - Orthopedic, Otorhinologic, Oral surgeries, AV fistulas, Plastic, Excision of lesion, Breast biopsy, Catheter ablation, Vascular stents and AV shunt

  6. Patient who requires local or regional 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 neurosurgical or cerebrovascular catheter procedures or interventions.
  5. Patient who require general anesthesia, epidural anesthesia or spinal anesthesia for surgery or procedure.
  6. Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
  7. Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.
  8. Patient diagnosed unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
  9. Patient whose heart rate less than 50 bpm, systolic blood pressure less than 90 mm Hg by the physical examination prior to the study drug administration.
  10. Patient has third degree heart block, unless the patient has a pacemaker.
  11. 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.
  12. Pregnant or lactating woman.
  13. In the Investigator's or subinvestigator's opinion, patient has any symptom or factor, 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: NCT01438931

Locations
Japan
Asahikawa Medical University Hospital
Asahikawa-City, Hokkaido, Japan
Hyogo Prefectural Amagasaki Hospital
Amagasaki, Hyogo, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan
Yuaikai Toyomijo Chuo Hospital
Toyomijo, Okinawa, Japan
Kansai Medical University Hirakata Hospital
Hirakata, Osaka, Japan
Osaka University Dental Hospital
Suita, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Shimane University Hospital
Izumo, Shimane, Japan
Tottori University Hospital
Yonago, Tottori, Japan
Kagoshima University Medical and Dental Hospital
Kagoshima, 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
Osaka Police Hospital
Osaka, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Japan
Keio University Hospital
Tokyo, Japan
Tokyo Women's Medical University Hospital
Tokyo, Japan
Sponsors and Collaborators
Hospira, Inc.
Maruishi Pharmaceutical
  More Information

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: July 23, 2015
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
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 July 24, 2016