NCT02250729Unknown不适用
Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study
Central Hospital, Nancy, France44 个研究点 分布在 1 个国家目标入组 1,020 人开始时间: 2014年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,020
- 试验地点
- 44
- 主要终点
- Exposure to pholcodine
研究概览
简要总结
The main objective of this study is to compare pholcodine exposure in patients having presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine exposure in matched anaesthetised patients with injection of NMBA, who did not present with an anaphylactic reaction (controls).
The secondary objectives of the study are:
- To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.
- To study the concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.
- To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.
- To study the association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.
- To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to (at least) one NMBA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥ 2 years old.
- •Referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of occurrence of peranaesthetic anaphylactic reaction during anaesthesia with administration of NMBAs (only for case patient).
- •Having given his/her consent (or the 2 parents consent for minors).
- •Affiliated with a social security scheme or dependent.
- •Able to answer a medicinal product intake questionnaire
- •In a clinical condition compatible with skin tests (no skin disease or psychiatric illness, etc.) (only for case patient)
- •Having stopped any anti-histamine treatment at least 8 days previously (only for case patient).
- •With positive skin test for the suspected NMBA (ony for case patient).
- •Patient anaesthetised in a control recruitment centre (only for control patients)
- •Having undergone anaesthesia with NMBA injection, without onset of peranaesthetic anaphylactic reaction whatever his medical history (only for control patients)
排除标准
- •Patients who have refused, or are unable to give their consent
- •Patients who have had negative control skin tests
- •Anaphylaxis suspected to be related to other drugs given on induction of anaesthesia, eg. antibiotics
- •Having presented with anaphylactic reaction during a previous anaesthesia without NMBA injection
- •Pregnant females at inclusion or during 12 months before anaesthesia
研究组 & 干预措施
cases with NMBA anaphylaxis
Experimental
Patients who experienced NMBA anaphylaxis during anesthesia
干预措施: Blood sampling (Other)
controls
Other
Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis
干预措施: Blood sampling (Other)
cases with NMBA anaphylaxis
Experimental
Patients who experienced NMBA anaphylaxis during anesthesia
干预措施: intradermal pholcodine allergy test in cases (Other)
结局指标
主要结局
Exposure to pholcodine
时间窗: within the 12 months before the anesthetic procedure
Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's
次要结局
- Impact of non subjective sources in pholcodine exposure assessment(within the 12 months preceeding general anesthetic procedure)
- Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.(Between 1 day to 12 weeks after the general anesthetic procedure)
- Concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.(within the 12 months preceeding the general anesthesia)
- Association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.(within the 12 months preceding the general anesthetic procedure)
- NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to one NMBA.(6 to 12 weeks after the general anesthetic procedure)
研究者
研究点 (44)
Loading locations...
相似试验
招募中
不适用
Effect of neuromuscular blockers in patients undergoing the day surgerySymptoms, signs and abnormal clinical and laboratory findings, NECKCT0004285Korea University Ansan Hospital60
已完成
不适用
Study the pharmacodynamics of neuromuscular blockade and selective relaxant-binding agent using the body composition measuring device in obese patients.obesityJPRN-UMIN000018194Institute of Biomedical Sciences Tokushima University Graduate School100
已完成
不适用
MEP and Neuromuscular BlockerBrain TumorNCT04768400Gangnam Severance Hospital100
Unknown
1 期
Effects of N-Methyl-D-Aspartate (NMDA)-Receptor Antagonism on Hyperalgesia, Opioid Use, and Pain After Radical ProstatectomyHyperalgesiaPainProstate CancerNCT00188383University Health Network, Toronto132
已完成
不适用
The effect of neuromuscular blocking agents on the management of mechaninal ventilation with supraglottic airway device and the influence of the differences between anesthetic agents or supraglottic airway devicesPatients scheduled for elective surgery under general anesthesiaJPRN-UMIN000027061ishinihon Hospital50