Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation

NCT ID: NCT01438931

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-03-31

Brief Summary

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.

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.

Conditions

Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

Loading infusion of Placebo over 10 minutes followed by maintenance infusion of Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

DA-9501

Intervention Type: DRUG

Dexmedetomidine hydrochloride variable dose

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

Group Type: ACTIVE_COMPARATOR

DA-9501

Intervention Type: DRUG

Dexmedetomidine hydrochloride variable dose

Interventions

DA-9501

Dexmedetomidine hydrochloride variable dose

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maruishi Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Hyogo Prefectural Amagasaki Hospital

Amagasaki, Hyōgo, Japan

Tsukuba University Hospital

Tsukuba, Ibaraki, Japan

Kagoshima University Medical and Dental Hospital

Kagoshima, Kagoshima-ken, Japan

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Kyoto, Japan

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Yuaikai Toyomijo Chuo Hospital

Toyomijo, Okinawa, Japan

Kansai Medical University Hirakata Hospital

Hirakata, Osaka, Japan

Kitano Hospital, The Tazuke Kofukai Medical Research Institute

Osaka, Osaka, Japan

Osaka Police Hospital

Osaka, Osaka, Japan

Osaka Saiseikai Nakatsu Hospital

Osaka, 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

Keio University Hospital

Tokyo, , Japan

Tokyo Women's Medical University Hospital

Tokyo, , Japan

Countries

Japan

References

Inagaki Y, Morita K, Ozaki M, Matsumoto K, Okayama A, Oya N, Hiraoka T, Takeda J. The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan. Yonago Acta Med. 2022 Jan 21;65(1):26-43. doi: 10.33160/yam.2022.02.005. eCollection 2022 Feb.

Reference Type: DERIVED

PMID: 35221758 (View on PubMed)

Other Identifiers

DEX-301

Identifier Type: -

Identifier Source: org_study_id