NCT01438931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 or Medical Procedure Without Intubation Under Monitored Sedation Care
Hospira, now a wholly owned subsidiary of Pfizer18 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2011年7月最近更新:
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
- 入组人数
- 162
- 试验地点
- 18
- 主要终点
- 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
研究概览
简要总结
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.
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 or medical procedure 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 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.
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 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.
研究组 & 干预措施
Placebo group
Placebo Comparator
Loading infusion of Placebo over 10 minutes followed by maintenance infusion of Placebo
干预措施: placebo (Drug)
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
干预措施: DA-9501 (Drug)
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
干预措施: DA-9501 (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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.)
- 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.)
- Visual Analogue Scale (VAS) score evaluation by Investigator or sub-investigator (ease of maintaining sedation level, hemodynamic stability, respiratory stability, subject's cooperativeness)(Within 24 hours after completion of the study drug administration)
- Percentage of time spent OAA/S Score 3 to 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.)
- Score evaluation of satisfaction and anxiety of the subject(Within 24 hours after completion of the study drug administration (as much as possible))
- 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.)
- Time to attain an Aldrete score ≥9 following discontinuation of the study drug infusion(Every 15 ± 2 minutes until the total score value becomes ≥9.)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
3 期
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without IntubationSedationNCT01438957Pfizer119
已完成
3 期
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)AnesthesiaSurgical Procedures, ElectiveNCT00398827Hospira, now a wholly owned subsidiary of Pfizer326
撤回
3 期
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart SurgeryDeliriumNCT00464763Hospira, now a wholly owned subsidiary of Pfizer
已完成
3 期
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation for Elective Awake Fiberoptic IntubationAwake Fiberoptic IntubationNCT00383890Hospira, now a wholly owned subsidiary of Pfizer124
已完成
2 期
Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational AgeAnesthesiaNCT01508455Hospira, now a wholly owned subsidiary of Pfizer6