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

NCT ID: NCT01438957

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-03
• Study Completion Date: 2011-11-18

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

Conditions

Sedation

Study Design

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

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Dexmedetomidine hydrochloride

Intervention Type: DRUG

Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

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

Group Type: EXPERIMENTAL

Dexmedetomidine hydrochloride

Intervention Type: DRUG

Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

Dexmedetomidine 0.5 mcg/kg

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

Group Type: EXPERIMENTAL

Dexmedetomidine hydrochloride

Intervention Type: DRUG

Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

Dexmedetomidine 1.0 mcg/kg

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

Group Type: EXPERIMENTAL

Dexmedetomidine hydrochloride

Intervention Type: DRUG

Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

Interventions

Dexmedetomidine hydrochloride

Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

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.

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

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

Sponsors

Maruishi Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Kochi Medical School Hospital

Nangoku, Kochi, Japan

Shinshul University Hospital

Matsumoto, Nagano, Japan

Shimane University Hospital

Izumo, Shimane, Japan

Tottori University Hospital

Yonago, Tottori, 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

Nippon Medical University Hospital

Tokyo, , Japan

Countries

Japan

References

Inagaki Y, Yamakage M, Sakamoto A, Okayama A, Oya N, Hiraoka T, Morita K. The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study. Yonago Acta Med. 2022 Jan 4;65(1):14-25. doi: 10.33160/yam.2022.02.002. eCollection 2022 Feb.

Reference Type: DERIVED

PMID: 35221757 (View on PubMed)

Other Identifiers

DEX-303

Identifier Type: -

Identifier Source: org_study_id