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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Sedation

Treatments: Drug: Dexmedetomidine hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01438957

DEX-303

Details and patient eligibility

About

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.

Full 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

Enrollment: 119 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Dexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose

Treatment:

Drug: Placebo

Dexmedetomidine 0.067 mcg/kg

Experimental group

Description:

Dexmedetomidine 0.4 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose

Treatment:

Drug: Dexmedetomidine hydrochloride

Dexmedetomidine 0.25 mcg/kg

Experimental group

Description:

Dexmedetomidine 1.5 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose

Treatment:

Drug: Dexmedetomidine hydrochloride

Dexmedetomidine 0.5 mcg/kg

Experimental group

Description:

Dexmedetomidine 3 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose

Treatment:

Drug: Dexmedetomidine hydrochloride

Dexmedetomidine 1.0 mcg/kg

Experimental group

Description:

Dexmedetomidine 6 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose

Treatment:

Drug: Dexmedetomidine hydrochloride