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

NCT01438957

Last updated date
Study Location
Nagoya University Hospital
Nagoya, Aichi, , Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sedation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sedation
Intervention  ICMJE
  • Drug: Dexmedetomidine hydrochloride
    Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Dexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose
    Intervention: 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
    Intervention: Drug: Dexmedetomidine hydrochloride
  • 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
    Intervention: Drug: Dexmedetomidine hydrochloride
  • 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
    Intervention: Drug: Dexmedetomidine hydrochloride
  • 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
    Intervention: Drug: Dexmedetomidine hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01438957
Other Study ID Numbers  ICMJE DEX-303
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Maruishi Pharmaceutical
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP