Clinical Study to Investigate the Efficacy and the Safety of Dexmedetomidine in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation
This study has been completed.
Sponsor:
Hospira, Inc.
Collaborator:
Maruishi Pharmaceutical
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01438957
First received: September 21, 2011
Last updated: May 23, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Evaluate the efficacy and the safety of Dexmedetomidine in sedation during surgery with epidural anesthesia or spinal anesthesia without intubation
| Condition | Intervention | Phase |
|---|---|---|
|
Sedation |
Drug: Dexmedetomidine hydrochloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation Under Monitored Sedation Care |
Resource links provided by NLM:
Further study details as provided by Hospira, Inc.:
Primary Outcome Measures:
- Observer's Assessment of Alertness/Sedation Score [ Time Frame: Every 5 minutes ] [ Designated as safety issue: No ]Incidence of patients who did not require rescue sedative to achieve and maintain adequate sedation level during the study drug administration
Secondary Outcome Measures:
- Observer's Assessment of Alertness/Sedation Score (OAA/S) [ Time Frame: Every 5 minutes ] [ Designated as safety issue: No ]Administration frequency and dosage of rescue sedative requried to achieve and maintain adequate sedation level during the study drug adminstration.
- Direct communication with the subject [ Time Frame: Continuously ] [ Designated as safety issue: No ]Incidence of patients who did not require rescue analgesia durign teh study drug administration.
- Clinical Symptoms [ Time Frame: Continuously ] [ Designated as safety issue: No ]Administration frequency and dosage of rescue analgesia during the study drug administration.
| Enrollment: | 120 |
| Study Start Date: | June 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: P |
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
|
| Active Comparator: Dexmedetomidine 0.067 ug/kg |
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
|
| Active Comparator: Dexmedetomidine 0.25 ug/kg |
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
|
| Active Comparator: Dexmedetomidine 0.5 ug/kg |
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
|
| Active Comparator: Dexmedetomidine 1.0 ug/kg |
Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
|
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
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation.
- ASA I to III Class.
- Patient undergoing a surgery requiring epidural or spinal anesthesia
Exclusion Criteria:
- Patient diagnosed unstable angina or acute myocardiac infarction within past 6 weeks.
- Patient whose heart rate less than 50 bpm, systolic blood pressure less than 90 mmHg.
- Patient has third degree heart block
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438957
Locations
| Japan | |
| Nagoya-City, Aichi, Japan | |
| Asahikawa-City, Hokkaido, Japan | |
| Sapporo-City, Hokkaido, Japan | |
| Nangoku-City, Kochi, Japan | |
| Kyoto-City, Kyoto, Japan | |
| Miyazaki-City, Miyazaki, Japan | |
| Matsumoto-City, Nagano, Japan | |
| Okayama-City, Okayama, Japan | |
| Osaka-City, Osaka, Japan | |
| Izumo-City, Shimane, Japan | |
| Bunkyo-ku, Tokyo, Japan | |
| Yonago-City, Tottori, Japan | |
Sponsors and Collaborators
Hospira, Inc.
Maruishi Pharmaceutical
More Information
No publications provided
| Responsible Party: | Hospira, Inc. |
| ClinicalTrials.gov Identifier: | NCT01438957 History of Changes |
| Other Study ID Numbers: | DEX-303 |
| Study First Received: | September 21, 2011 |
| Last Updated: | May 23, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Hospira, Inc.:
|
Dexmedetomidine Sedation Non-intubation epidural anesthesia spinal anesthesia |
Additional relevant MeSH terms:
|
Anesthetics Dexmedetomidine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 13, 2013