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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2021-03-22

Study results available
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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

Interventions

DRUG

Dexmedetomidine hydrochloride

Dexmedetomidine 0.2 to 0.7 mcg/kg/hr

DRUG

Placebo

Sponsors & Collaborators

  • Maruishi Pharmaceutical

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-03
Primary Completion
2011-11-18
Completion
2011-11-18
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01438957 on ClinicalTrials.gov