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

Sedation Clinical Trial

Official title:

Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation Under Monitored Sedation Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438931
• Other study ID #: DEX-301
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2011
• Last updated: July 23, 2015
• Start date: July 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2015
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• DA-9501
Dexmedetomidine hydrochloride variable dose
• placebo

Locations

Country	Name	City	State
Japan	Hyogo Prefectural Amagasaki Hospital	Amagasaki	Hyogo
Japan	Asahikawa Medical University Hospital	Asahikawa-City	Hokkaido
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Kansai Medical University Hirakata Hospital	Hirakata	Osaka
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Kagoshima University Medical and Dental Hospital	Kagoshima
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	Osaka Police Hospital	Osaka
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka
Japan	Osaka University Dental Hospital	Suita	Osaka
Japan	Keio University Hospital	Tokyo
Japan	Tokyo Women's Medical University Hospital	Tokyo
Japan	Yuaikai Toyomijo Chuo Hospital	Toyomijo	Okinawa
Japan	Tsukuba University Hospital	Tsukuba	Ibaraki
Japan	Tottori University Hospital	Yonago	Tottori

Sponsors (2)

Lead Sponsor	Collaborator
Hospira, Inc.	Maruishi Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of patients who did not require rescue administration of propofol to achieve and maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score =4 during the study drug administration		Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.	No
Secondary	Administration frequency and dosage of propofol required to achieve and maintain OAA/S score =4 during the study drug administration	If the OAA/S score is 5, 0.2 mg/kg of propofol as a sedative is administered intravenously by slow "IV push" and the administration is to be repeated until the target level of sedation (OAA/S score =4) is achieved.	After the start of study drug (20 ± 2 minutes), if the OAA/S score is 5.	No
Secondary	Time to first rescue administration of propofol		=15 minutes after the start of study drug infusion.	No
Secondary	Incidence of patients who did not require rescue administration of fentanyl during the study drug administration		After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be =15 minutes.	No
Secondary	Administration frequency and dosage of fentanyl required during the study drug administration		After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be =15 minutes.	No
Secondary	Percentage of time spent OAA/S Score =4 during the study drug infusion		Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.	No
Secondary	Percentage of time spent OAA/S Score 3 to 4 during the study drug infusion		Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.	No
Secondary	Time to attain an Aldrete score =9 following discontinuation of the study drug infusion		Every 15 ± 2 minutes until the total score value becomes =9.	No
Secondary	Visual Analogue Scale (VAS) score evaluation by Investigator or sub-investigator (ease of maintaining sedation level, hemodynamic stability, respiratory stability, subject's cooperativeness)		Within 24 hours after completion of the study drug administration	No
Secondary	Score evaluation of satisfaction and anxiety of the subject		Within 24 hours after completion of the study drug administration (as much as possible)	No