NCT04237792已完成4 期
A PHASE 3/4 RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF DEXMEDETOMIDINE (DEX) USED WITH PROPOFOL (PRO) AS NEEDED FOR PROCEDURAL SEDATION OF PEDIATRIC SUBJECTS ≥1 MONTH TO <17 YEARS OF AGE UNDERGOING MRI SCANS
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 128
- 试验地点
- 23
- 主要终点
- Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
研究概览
简要总结
This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to <17 years of age undergoing MRI scans in the US and Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject ≥1 month and <17 years of age.
- •American Society of Anesthesiologists (ASA) Physical Status I, II or III.
- •Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or other proceduralist in attendance.
- •Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete
排除标准
- •Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects.
- •Weight on Day 1 before randomization is less than the 10th percentile of weight for age and sex in the US and Japan or is greater than the 95th percentile of weight for age and sex in the US or greater than the 97th percentile of weight for age and sex in Japan based on sponsor-provided growth charts.
- •Planned medical procedure during the MRI scan or post-MRI recovery period.
- •Requires endotracheal intubation or laryngeal mask airway (LMA).
- •Known allergy to eggs, egg products, soybeans or soybean products.
- •SpO2 <93 % on room air -
研究组 & 干预措施
dexmedetomidine low dose group
Experimental
low dose of dexmedetomidine to be given
干预措施: dexmedetomidine (Drug)
dexmedetomidine low dose group
Experimental
low dose of dexmedetomidine to be given
干预措施: propofol (Drug)
dexmedetomidine middle dose group
Experimental
middle dose of dexmedetomidine to be given
干预措施: dexmedetomidine (Drug)
dexmedetomidine middle dose group
Experimental
middle dose of dexmedetomidine to be given
干预措施: propofol (Drug)
dexmedetomidine high dose group
Experimental
high dose of dexmedetomidine to be given
干预措施: dexmedetomidine (Drug)
dexmedetomidine high dose group
Experimental
high dose of dexmedetomidine to be given
干预措施: propofol (Drug)
结局指标
主要结局
Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
时间窗: Up to maximum of 3 hours during MRI scan on Day 1
Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.
次要结局
- Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age(Up to maximum of 3 hours during MRI scan on Day 1)
- Emergence Time - By Age Cohort and Combined Age(Post MRI scan on Day 1 up to 24 hours)
- Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age(Up to maximum of 3 hours during MRI scan on Day 1)
- Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI(Up to maximum of 3 hours during MRI scan on Day 1)
- Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI(Up to maximum of 3 hours during MRI scan on Day 1)
- Number of Participants Who Received PRO - By Age Cohort and Combined Age(Up to maximum of 3 hours during MRI scan on Day 1)
- Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age(Up to maximum of 3 hours during MRI scan on Day 1)
- Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age(Up to maximum of 3 hours during MRI scan on Day 1)
研究者
研究点 (23)
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