Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Maruishi Pharmaceutical
Conditions:
Sedation
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 int...
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 patien...
Eligibility Criteria
Inclusion
- Patient has signed and dated the Informed Consent after the study had been fully explained.
- Patient is male or female, at least 20 years of age when the Informed Consent is obtained.
- American Society for Anesthesiologists (ASA) I to III Class.
- Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.
- Patient undergoing a surgery requiring epidural or spinal anesthesia
Exclusion
- Patient who underwent general anesthesia within 7 days, or who received other study drugs within 30 days from the date of consent.
- Patient with \<92% SpO2, at the physical examination prior to the study drug administration, or ventilatory failure which requires intubation or Laryngeal Mask.
- 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.
- Patient who require general anesthesia.
- Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
- Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.
- Patient diagnosed with unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
- Patient whose heart rate is \<60 bpm, systolic blood pressure is \<90 mmHg by the physical examination prior to the study drug administration.
- Patient has third degree heart block, unless the patient has a pacemaker or transverse pacing wires are in place.
- 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.
- Pregnant or lactating woman.
- 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
Key Trial Info
Start Date :
June 3 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2011
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT01438957
Start Date
June 3 2011
End Date
November 18 2011
Last Update
March 22 2021
Active Locations (12)
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1
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
2
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan
3
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
4
Kochi Medical School Hospital
Nangoku, Kochi, Japan