NCT01438957已完成3 期
Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation Under Monitored Sedation Care
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 119
- 试验地点
- 12
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
Dexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose
干预措施: Placebo (Drug)
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
干预措施: Dexmedetomidine hydrochloride (Drug)
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
干预措施: Dexmedetomidine hydrochloride (Drug)
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
干预措施: Dexmedetomidine hydrochloride (Drug)
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
干预措施: Dexmedetomidine hydrochloride (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Time to First Rescue Administration of Propofol(During the study drug infusion period (≥15 minutes [Approximate]))
- 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.)
- 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.)
- Dosage of Fentanyl Dosing Required During the Study Drug Administration.(During the study drug administration)
- Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery")(Within 24 hours after completion of the study drug administration (as much as possible))
- Number of Fentanyl Dosing Required During the Study Drug Administration.(During the study drug administration)
- Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion(Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8.)
- Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level)(Within 24 hours after completion of the study drug administration)
- Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation)(Within 24 hours after completion of the study drug administration)
- Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure")(Within 24 hours after completion of the study drug administration (as much as possible))
- Score Evaluation of Satisfaction and Anxiety of the Subject ("If You May Undergo a Similar Surgery, the Same Anesthesia Procedure Will be Requested for the Next Time")(Within 24 hours after completion of the study drug administration (as much as possible))
- Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery")(Within 24 hours after completion of the study drug administration (as much as possible))
- 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.)
- Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State)(Within 24 hours after completion of the study drug administration)
- Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State)(Within 24 hours after completion of the study drug administration)
- Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion(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.)
- Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion(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.)
- Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery")(Within 24 hours after completion of the study drug administration (as much as possible))
- Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery")(Within 24 hours after completion of the study drug administration (as much as possible))
研究者
研究点 (12)
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