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

NCT01438957 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DEX-303
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 12

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.

Conditions

Sedation

Keywords

Dexmedetomidine; Sedation; Non-intubation; epidural anesthesia; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Percentage 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 after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.

Secondary Outcomes (19)

• Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration

  15 minutes after the start of study drug, if the OAA/S score is 5.

• Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration

  15 minutes after the start of study drug, if the OAA/S score is 5.

• Time to First Rescue Administration of Propofol

  During the study drug infusion period (≥15 minutes [Approximate])

• Percentage 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.

• Number of Fentanyl Dosing Required During the Study Drug Administration.

  During the study drug administration

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Dexmedetomidine 0.067 mcg/kg

EXPERIMENTAL

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

Drug: Dexmedetomidine hydrochloride

Dexmedetomidine 0.25 mcg/kg

EXPERIMENTAL

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

Drug: Dexmedetomidine hydrochloride

Dexmedetomidine 0.5 mcg/kg

EXPERIMENTAL

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

Drug: Dexmedetomidine hydrochloride

Dexmedetomidine 1.0 mcg/kg

EXPERIMENTAL

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

Drug: Dexmedetomidine hydrochloride

Interventions

Dexmedetomidine hydrochloride DRUG

Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

Dexmedetomidine 0.067 mcg/kg; Dexmedetomidine 0.25 mcg/kg; Dexmedetomidine 0.5 mcg/kg; Dexmedetomidine 1.0 mcg/kg

Placebo DRUG

Placebo

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.
• Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.
• Patient undergoing a surgery requiring epidural or spinal 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 general anesthesia.
• 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 with unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
• Patient whose heart rate is \<60 bpm, systolic blood pressure is \<90 mmHg by the physical examination prior to the study drug administration.
• Patient has third degree heart block, unless the patient has a pacemaker or transverse pacing wires are in place.
• 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, the patient has any symptom or condition which might increase risk to the patient by conducting the study or preclude obtaining satisfactory study data

Sponsors & Collaborators

• Pfizer: lead
• Maruishi Pharmaceutical: collaborator

Study Sites (12)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Location

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Location

Kochi Medical School Hospital

Nangoku, Kochi, Japan

Location

Shinshul University Hospital

Matsumoto, Nagano, Japan

Location

Shimane University Hospital

Izumo, Shimane, Japan

Location

Tottori University Hospital

Yonago, Tottori, Japan

Location

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan

Location

University of Miyazaki Hospital

Miyazaki, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Kitano Hospital, The Tazuke Kofukai Medical Research Institute

Osaka, Japan

Location

Nippon Medical University Hospital

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 35221757 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 3, 2011
• Primary Completion: November 18, 2011
• Study Completion: November 18, 2011
• Last Updated: March 22, 2021
• Results First Posted: March 22, 2021

Record last verified: 2021-03

Locations

JP (12)