中国临床试验-注册-详情页研究信息

{ "code": 200, "msg": "查询成功", "data": [ { "primary_sponsor": { "chs": "陆军军医大学第二附属医院", "eng": "The Second Affiliated Hospital of Army Medical University" }, "sponsor_address": { "chs": "重庆市新桥医院麻醉科 400037", "eng": "Department of Anaesthesia, Xinqiao Hospital, Chongqing, 400037" }, "secondary_sponsor": [ { "city_chs": "", "city_eng": "", "address_chs": "重庆市新桥医院麻醉科 400037", "address_eng": "Department of Anaesthesia, Xinqiao Hospital, Chongqing, 400037", "country_chs": "中国", "country_eng": "China", "province_chs": "重庆", "province_eng": "ChongQing", "institution_hospital_chs": "陆军军医大学第二附属医院", "institution_hospital_eng": "The Second Affiliated Hospital of Army Medical University" } ], "source_funding": { "chs": "自筹", "eng": "self-collected" }, "study_disease": "疼痛", "disease_code": null, "study_type": "Interventional study", "clinical_phase": "New Treatment Measure Clinical Study", "objectives_study": { "chs": "了解极化液对剖宫产手术后患者疼痛的影响，为临床宫缩痛治疗提供新的策略。", "eng": "To understand the influence of polarized fluid on the pain of patients after cesarean section, and to provide a new strategy for the clinical treatment of uterine contractions." }, "medicine_treatment_detail": { "chs": "纳入的受试者根据随机数字随机进入极化液组和对照组，镇痛方式为目前临床常规使用的镇痛方法（曲马多800mg+生理盐水共300ml，6ml/h），麻醉、手术、术后治疗均按照临床常规进行。用药后研究者对所有患者进行术后问卷调查", "eng": "The subjects were randomly assigned to the polarization fluid group and the control group according to the random numbers. The analgesic method was the current routine clinical analgesia method (Tramadol 800mg+ normal saline 300ml, 6ml/h). Anesthesia, surgery and postoperative treatment were conducted according to the clinical routine.Postoperative questionnaires were administered to all patients" }, "study_design": { "chs": "病例对照研究", "eng": "Case-Control study" }, "inclusion_criteria": { "chs": [ "1)\t年龄20-40岁；", "2)\tSAⅠ-Ⅱ级\t；", "3)\t单胎足月妊娠患者；", "4)\t自愿签署剖宫产手术及术后自控镇痛知情同意书的患者；", "5)\t愿意参加本研究并签署知情同意书。" ], "eng": [ "1) 20-40 years old;", "2) ASA Ⅰ - Ⅱ ;", "(3) Patients with single-birth pregnancy;", "4) Patients who voluntarily sign informed consent forms for cesarean section operation and postoperative self-control analgesia;", "5) Willing to participate in this study and sign the informed consent." ] }, "exclusion_criteria": { "chs": [ "1）、精神病史或正在使用精神类药品治疗；", "2）、妊娠糖尿病、高血压合并重度子痫；", "3）、产前已知的抑郁症或躁郁症病史\t；", "4）、自杀倾向或自杀历史者；", "5）、吸毒、酒精或阿片类药物滥用史；", "6）、正在或过去2周内接受过单胺氧化酶（MAO）抑制剂治疗；", "7）、阿片类药物、曲马多过敏者；", "8）、中枢神经系统疾病如癫痫等；", "9）、其他心、脑、肝、肾以及造血系统等严重疾病者\t；", "10)、入选研究前3月服用了其他试验药或者是参与了其他临床试验；", "11）、任何原因不能配合研究或研究者认为不宜纳入本试验。" ], "eng": [ ") A history of mental illness or treatment with psychotropic drugs;", "2) Gestational diabetes mellitus and hypertension complicated with severe eclampsia;", "3) A known prenatal history of depression or bipolar disorder;", "4) Suicidal tendency or history of suicide;", "5) A history of drug, alcohol or opioid abuse;", "6) Being or receiving monoamine oxidase (MAO) inhibitor treatment in the past 2 weeks;", "7) Allergic to opioids or tramadol;", "8), central nervous system diseases such as epilepsy;", "9), other serious diseases of the heart, brain, liver, kidney and hematopoietic system;", "10) Taking other experimental drugs or participating in other clinical trials three months before the inclusion in the study;", "11) Cannot cooperate with the study for any reason or the researcher considers it inappropriate to be included in this study." ] }, "execute_time_start": "2020-12-30", "execute_time_end": "2021-12-30", "recruiting_time_start": "2020-12-30", "recruiting_time_end": "2021-12-30", "interventions_info": [ { "group_chs": "2", "group_eng": "2", "sample_size": "70", "intervention_chs": "极化液", "intervention_eng": "glucose-insulin-potassium", "intervention_code": "" }, { "group_chs": "2", "group_eng": "2", "sample_size": "70", "intervention_chs": "使用极化液", "intervention_eng": "use glucose-insulin-potassium", "intervention_code": "" } ], "recruitment_research": [ { "city_chs": "", "city_eng": "", "country_chs": "中国", "country_eng": "China", "province_chs": "重庆", "province_eng": "ChongQing", "level_institution_chs": "三甲医院", "level_institution_eng": "The top three", "institution_hospital_chs": "陆军军医大学第二附属医院", "institution_hospital_eng": "The Second Affiliated Hospital of Army Medical University" }, { "city_chs": "", "city_eng": "", "country_chs": "中国", "country_eng": "China", "province_chs": "重庆", "province_eng": "Chongqing", "level_institution_chs": "三甲", "level_institution_eng": "The top three", "institution_hospital_chs": "陆军军医大学第二附属医院", "institution_hospital_eng": "The Second Affiliated Hospital of Army Medical University" } ], "outcomes_info": [ { "type_chs": "主要指标", "type_eng": "Primary indicator", "outcome_chs": "疼痛", "outcome_eng": "pain", "measure_time_chs": "", "measure_time_eng": "", "measure_method_chs": "", "measure_method_eng": "" } ], "sample_participants": [ { "note_chs": "", "note_eng": "", "tissue_chs": "子宫", "tissue_eng": "uterus", "fate_sample_chs": "使用后销毁", "fate_sample_eng": "Destruction after use", "sample_name_chs": "血液", "sample_name_eng": "Blood" } ], "status_name": "尚未招募", "min_age": "20", "max_age": "45", "sex_info": "Female", "randomization_procedure": { "chs": "本项目主要结局变量患者术后注射缩宫素后10minVAS评分，预实验得到疼痛VAS评分为35.9，标准差22.9，以0.5SD差异作为临床意义参考，设定检验水准α为0.05，检验效能0.80，通过利用样本量计算软件PASS11.0，采用计算最小样本量为每组64例，考虑大约10%的失访率，需要每组最小总样本量为70例，总样本量为140例。", "eng": "This project mainly outcome variables in patients with postoperative 10 min VAS score after injection of oxytocin, preliminary experiment get pain VAS score is 35.9, the standard deviation of 22.9, 0.5 SD differences for clinical reference, set the inspection level alpha was 0.05, 0.80 inspection efficiency, by" } } ] }

中国临床试验-注册-详情页研究信息

中国临床试验-注册-详情页研究信息

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