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

NCT01438931 | Completed Phase 3

• 1 other identifier: DEX-301
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 18

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.

Conditions

Sedation

Keywords

Dexmedetomidine; Sedation; Non-intubation; local anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (9)

• Administration frequency and dosage of propofol required to achieve and maintain OAA/S score ≤4 during the study drug administration

  After the start of study drug (20 ± 2 minutes), if the OAA/S score is 5.

• Time to first rescue administration of propofol

  ≥15 minutes after the start of study drug infusion.

• 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.

• 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.

• 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.

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

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

Drug: placebo

DA-9501 0.5 mcg/kg group

ACTIVE COMPARATOR

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

Drug: DA-9501

DA-9501 1.0 mcg/kg group

ACTIVE COMPARATOR

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

Drug: DA-9501

Interventions

DA-9501 DRUG

Dexmedetomidine hydrochloride variable dose

DA-9501 0.5 mcg/kg group; DA-9501 1.0 mcg/kg group

placebo DRUG

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 at the preoperative diagnosis.
• New York Heart Association (NYHA) classification is I to III (Only patients who need classification of cardiac performance.)
• 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
• Patient who requires local or regional anesthesia.

You may not qualify if:

• 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 neurosurgical or cerebrovascular catheter procedures or interventions.
• Patient who require general anesthesia, epidural anesthesia or spinal anesthesia for surgery or procedure.
• 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 unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
• 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.
• Patient has third degree heart block, unless the patient has a pacemaker.
• 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, patient has any symptom or factor, which might increase risk to the patient by conducting the study or preclude obtaining satisfactory study data.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead
• Maruishi Pharmaceutical: collaborator

Study Sites (18)

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Location

Hyogo Prefectural Amagasaki Hospital

Amagasaki, Hyōgo, Japan

Location

Tsukuba University Hospital

Tsukuba, Ibaraki, Japan

Location

Kagoshima University Medical and Dental Hospital

Kagoshima, Kagoshima-ken, Japan

Location

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Kyoto, Japan

Location

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, Japan

Location

Yuaikai Toyomijo Chuo Hospital

Toyomijo, Okinawa, Japan

Location

Kansai Medical University Hirakata Hospital

Hirakata, Osaka, Japan

Location

Kitano Hospital, The Tazuke Kofukai Medical Research Institute

Osaka, Osaka, Japan

Location

Osaka Police Hospital

Osaka, Osaka, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, Osaka, Japan

Location

Osaka University Dental Hospital

Suita, Osaka, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Location

Shimane University Hospital

Izumo, Shimane, Japan

Location

Tottori University Hospital

Yonago, Tottori, Japan

Location

Keio University Hospital

Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 35221758 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 22, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

JP (18)