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佐剂辅助髂静脉阻滞对老年髋关节手术患者术后谵妄的影响：一项前瞻性、随机对照试验
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注册号：

Registration number：

 ChiCTR2500097803 

最近更新日期：

Date of Last Refreshed on：

 2025-02-26 08:27:38 

注册时间：

Date of Registration：

 2025-02-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

佐剂辅助髂静脉阻滞对老年髋关节手术患者术后谵妄的影响：一项前瞻性、随机对照试验

Public title：

The Effect of Local Anesthetic Adjuvants for Iliac Fascia Compartment Block on Postoperative Delirium in Elderly Patients Undergoing Elective Hip Surgery: A Prospective, Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

佐剂辅助髂静脉阻滞对老年髋关节手术患者术后谵妄的影响：一项前瞻性、随机对照试验

Scientific title：

The Effect of Local Anesthetic Adjuvants for Iliac Fascia Compartment Block on Postoperative Delirium in Elderly Patients Undergoing Elective Hip Surgery: A Prospective, Randomized Controlled Trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

王世萍 

研究负责人：

徐进 

Applicant：

Shiping Wang 

Study leader：

Jin Xu 

申请注册联系人电话：

Applicant telephone：

 +86 137 5373 6592

研究负责人电话：

Study leader's
telephone：

+86 139 2049 0278

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 13753736592@163.com

研究负责人电子邮件：

Study leader's E-mail：

 doctorjinjin@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

天津市河北区中山路1号天津市第四中心医院研究生公寓

研究负责人通讯地址：

天津市河西区解放南路406号天津市天津医院

Applicant address：

Graduate student apartment, Tianjin Fourth Central Hospital, No. 1 Zhongshan Road, Hebei District, Tianjin

Study leader's address：

Tianjin Hospital, 406 Jiefang South Road, Hexi District, Tianjin

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

天津大学,医学院,麻醉学

Applicant's institution：

Department of Anesthesiology, School of Medicine, Tianjin University

研究负责人所在单位：

天津医院,麻醉科

Affiliation of the Leader：

Department of Anesthesiology,Tianjin Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2024医伦审230

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

天津医院医学伦理委员会

Name of the ethic committee：

Tianjin Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-12-30 00:00:00

伦理委员会联系人：

戴滨

Contact Name of the ethic committee：

Bin Dai

伦理委员会联系地址：

天津市河西区解放南路406号天津市天津医院

Contact Address of the ethic committee：

Tianjin Hospital, 406 Jiefang South Road, Hexi District, Tianjin

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 138 2166 0135

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 daibincn@sina.com

研究实施负责（组长）单位：

天津医院

Primary sponsor：

Tianjin Hospital

研究实施负责（组长）单位地址：

天津市河西区解放南路406号天津市天津医院

Primary sponsor's address：

Tianjin Hospital, 406 Jiefang South Road, Hexi District, Tianjin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

天津市

市(区县)：

河西区

Country：

China

Province：

Tianjin

City：

Hexi

单位(医院)：

天津医院

具体地址：

天津市河西区解放南路406号

Institution
hospital：

Tianjin Hospital

Address：

406 Jiefang South Road, Hexi District, Tianjin

经费或物资来源：

自主研究

Source(s) of funding：

Independent research

研究疾病：

术后谵妄  

Target disease：

Postoperative Delirium

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

明确佐剂辅助髂筋膜阻滞可以减轻老年髋部手术术后谵妄的发生； 比较不同佐剂辅助髂筋膜阻滞对老年髋部手术术后谵妄的影响； 为术后谵妄的作用机制提供价值； 探索个性化治疗方案。  

Objectives of Study：

To clarify that adjuvant - assisted iliac fascia block can reduce the occurrence of postoperative delirium in elderly patients undergoing hip surgery. To compare the effects of different adjuvant - assisted iliac fascia blocks on postoperative delirium in elderly patients undergoing hip surgery. To provide value for the mechanism of postoperative delirium. To explore personalized treatment plans.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1、患者拒绝使用地塞米松、右美托咪定、艾司氯胺酮； 2、患者有使用地塞米松、右美托咪定、艾司氯胺同禁忌症； 3、怀疑麻醉药中毒反应； 4、伴有任何严重疾病，预计生存期＜6 个月； 5、不能表达主观不适症状者； 6、术后去 ICU 患者； 7、研究者认为不适合参加本研究的其他情况； 8、髂筋膜阻滞或椎管内操作失败者。

Exclusion criteria：

1. The patient refused to use dexamethasone, dexmedetomidine, and ketamine; 2. The patient has contraindications for the use of dexamethasone, dexmedetomidine, and escitalopram; 3. Suspected anesthesia poisoning reaction; 4. Accompanied by any serious illness, expected survival time<6 months; 5. Individuals who cannot express subjective discomfort symptoms; 6. Postoperative ICU patients; 7. Other situations that the researcher deems unsuitable for participation in this study; 8. Failed iliac fascia block or spinal canal operation.

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2026-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-03-01 00:00:00 至 To 2026-03-01 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 55

Group：

Group A

Sample size：

干预措施：

右美托咪定1 μg·kg-1

干预措施代码：

Intervention：

Dexmedetomidine 1 μg·kg-1

Intervention code：

组别：

B组

样本量：

 55

Group：

Group B

Sample size：

干预措施：

地塞米松 0.1mg·kg-1

干预措施代码：

Intervention：

Dexamethasone 0.1mg·kg-1

Intervention code：

组别：

C组

样本量：

 55

Group：

Group C

Sample size：

干预措施：

艾司氯胺酮0.5mg·kg-1

干预措施代码：

Intervention：

Esketamine0.5mg·kg-1

Intervention code：

组别：

D组

样本量：

 55

Group：

Group D

Sample size：

干预措施：

生理盐水

干预措施代码：

Intervention：

normal saline

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 天津市 

市(区县)：

 河西区 

Country：

China

Province：

Tianjin

City：

Hexi District

单位(医院)：

 天津医院 

单位级别：

 三级，三甲 

Institution
hospital：

Tianjin Hospital

Level of the institution：

Tertiary, Tertiary A

测量指标：

Outcomes：

指标中文名：

术后谵妄发生率

指标类型：

主要指标

Outcome：

Incidence of postoperative delirium

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

失眠发生率

指标类型：

次要指标

Outcome：

Insomnia incidence rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

VAS评分

指标类型：

次要指标

Outcome：

VAS scores

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

RASS评分

指标类型：

次要指标

Outcome：

RASS scores

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术前、术后C反应蛋白（CRP）

指标类型：

次要指标

Outcome：

Preoperative and postoperative C-reactive protein (CRP)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术前、术后C反应蛋白 IL-6

指标类型：

次要指标

Outcome：

Preoperative and postoperative IL-6

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

围手术期不良反应的病例数

指标类型：

副作用指标

Outcome：

Number of cases with perioperative adverse reactions

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 65 岁 years
最大 Max age 90 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由研究人员将220名患者采用电脑软件生成随机数字编号，分为 4 组，每组55例。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The researchers used computer software to generate random numbers for 220 patients and divided them into four groups with 55 cases in each group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

三盲：在研究结束前，受试者和研究者以及数据统计者均不知晓分组治疗结果。

Blinding：

Triple blinding: Before the end of the study, neither the subjects, the investigator nor the statistician knew the results of the group treatment.

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

unshared

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

（1）研究分组 将240名患者采用电脑软件生成随机数字编号，分为 4 组，每组60例。D 组为空白对照组；A组为右美托咪定组，术中输注右美托咪定；B组为地塞米松组；C 组为艾司氯胺酮组。 （2）术前准备 患者入院后立即行相关术前检查及术前宣教，评估患者病情，力争在入院后 24~48小时内完成手术。术前对患者行简易精神状态检查评分，评估患者认知功能。 （3）麻醉方法 所有患者均不使用术前用药，入手术室后先采取超声引导下髂筋膜阻滞，干预组A组：超声引导下髂筋膜室阻滞[0.33%罗哌卡因30mL和2mL含右美托咪定1 ug/kg 的生理盐水]；干预组B组：超声引导下髂筋膜室阻滞[0.33%罗哌卡因30mL和2mL含4mg地塞米松的生理盐水]；干预组C组：超声引导下髂筋膜室阻滞[0.33%罗哌卡因30mL和2mL含20mg艾司氯胺酮的生理盐水]；对照组D组：超声引导下髂筋膜室阻滞[0.33%罗哌卡因30mL和2mL生理盐水]，观察到药液存在于骼筋膜与骼腰肌之间的间隙内并向股神经扩散则视为穿刺成功。然后所有患者取侧卧位行椎管内穿刺，行腰硬联合麻醉，蛛网膜下腔注射 0.5%盐酸罗哌卡因 12.5 mg，调节麻醉平面至 T8~S5 水平。手术达到 2小时硬膜外注射 2%利多卡因 5mL。阻滞由专业的麻醉医生在超声引导下进行，所有患者也接受了最理想的围手术期多模式镇痛治疗。为预防相关的恶心呕吐等副作用，所有患者均在术中静脉给予昂丹司琼4mg。 （4）术中管理 采用输液及血管活性药物维持患者术中 SBP 在 110~140 mmHg 之间，MAP 在 60~90mmHg 之间。对没有基础疾病的患者，在其血红蛋白低于 70 g/L 时考虑输血；对具有冠心病及脑血管意外病史的患者，维持其血红蛋白>90 g/L。 （5）术后管理 术后常规送 PACU 观察，评估其入室后即刻、30 分钟、90 分钟的 RASS 以及 VAS评分,当 VAS 评分>4 时使用 50 mg 氟比洛芬酯。 （6）术后访视 术后第 1 天至第 3天对患者进行访视，评估患者的 VAS 评分；使用 CAM 评分量表对患者进行评估。所有患者的随访由同一人（实验数据收集者）进行，并根据观察时间表收集临床数据，如果发生其他并发症，则对患者进行手术治疗。 （7）检测指标及数据收集 主要结局：PACU 期间、术后第 1 天（D1）、第 2 天（D2）、第 3 天（D3）CAM 评分，CAM 评分 > 19 分评定为 POD。 次要结局：1、记录患者的性别、年龄（岁）、体重（kg）、ASA分级、合并疾病、术前简易精神状态评分、术前诊断、手术名称、入院到手术的时间、手术持续时间（min）、PACU持续时间（min）、输血、自体血、术中追加局麻药的次数和剂量。 2、术前、术后C反应蛋白（CRP）、血沉（ESR）。 3、四组患者入手术室休息5 min（T0）、髂筋膜阻滞前（T1）、髂筋膜阻滞后30 min（T2）、椎管内阻滞前（T3）、椎管内阻滞后（T4）、手术切口时（T5）、手术切口后20 min（T6）、转出手术室时（T7）、离开恢复室后（T8）各时间点的心率值。 4、T1、PACU、D1、D2的VAS，术前当天、手术当天、D1 和 D2 失眠的发生率。 5、围手术期不良反应（包括恶心、呕吐、低血压、高血压和神经阻滞相关并发症）的病例数（局部麻醉剂毒性、神经损伤、局部血肿和感染）。 6、阻滞后24小时内需要补救性镇痛药的病例数（例）。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

(1) Research Grouping A total of 240 patients were assigned random number codes generated by computer software and divided into 4 groups, with 60 cases in each group. Group D served as the blank control group; Group A was the dexmedetomidine group, receiving an intraoperative infusion of dexmedetomidine; Group B was the dexamethasone group; and Group C was the esketamine group. (2) Preoperative Preparation Upon admission, patients immediately underwent relevant preoperative examinations and received preoperative education. Their conditions were evaluated, and every effort was made to complete the surgery within 24 to 48 hours after admission. Before the operation, patients were scored using the Mini-Mental State Examination to assess their cognitive function. (3) Anesthesia Method All patients did not receive any preoperative medications. After entering the operating room, they first underwent ultrasound-guided iliac fascia block. For the intervention group A: Ultrasound-guided iliac fascia compartment block was performed with [30 mL of 0.33% ropivacaine and 2 mL of normal saline containing 1 μg/kg of dexmedetomidine]; for the intervention group B: Ultrasound-guided iliac fascia compartment block was carried out with [30 mL of 0.33% ropivacaine and 2 mL of normal saline containing 4 mg of dexamethasone]; for the intervention group C: Ultrasound-guided iliac fascia compartment block was conducted with [30 mL of 0.33% ropivacaine and 2 mL of normal saline containing 20 mg of esketamine]; for the control group D: Ultrasound-guided iliac fascia compartment block was implemented with [30 mL of 0.33% ropivacaine and 2 mL of normal saline]. The puncture was considered successful when the liquid medicine was observed in the space between the iliac fascia and the iliopsoas muscle and diffused towards the femoral nerve. Then, all patients were placed in the lateral position for spinal canal puncture, and combined spinal-epidural anesthesia was performed. 12.5 mg of 0.5% ropivacaine hydrochloride was injected into the subarachnoid space, and the anesthesia plane was adjusted to the T8-S5 level. When the operation reached 2 hours, 5 mL of 2% lidocaine was injected epidurally. The block was performed by a professional anesthesiologist under ultrasound guidance, and all patients also received the most optimal perioperative multimodal analgesia treatment. To prevent side effects such as nausea and vomiting, all patients were intravenously administered 4 mg of ondansetron during the operation. (4) Intraoperative Management Intravenous infusion and vasoactive drugs were used to maintain the patients' systolic blood pressure (SBP) between 110 and 140 mmHg and mean arterial pressure (MAP) between 60 and 90 mmHg during the operation. For patients without underlying diseases, blood transfusion was considered when their hemoglobin level was lower than 70 g/L; for patients with a history of coronary heart disease and cerebrovascular accident, their hemoglobin level was maintained above 90 g/L. (5) Postoperative Management After the operation, patients were routinely sent to the Post-Anesthesia Care Unit (PACU) for observation. The Richmond Agitation-Sedation Scale (RASS) and Visual Analogue Scale (VAS) scores were evaluated immediately upon admission to the PACU, at 30 minutes, and at 90 minutes. When the VAS score was > 4, 50 mg of flurbiprofen axetil was administered. (6) Postoperative Follow-up Patients were followed up from the first day to the third day after the operation, and their VAS scores were evaluated. The Confusion Assessment Method (CAM) scale was used to evaluate the patients. All patients were followed up by the same person (the collector of experimental data), and clinical data were collected according to the observation schedule. If other complications occurred, the patients would undergo surgical treatment. (7) Detection indicators and data collection Primary Outcome: CAM scores during the PACU period, on the 1st (D1), 2nd (D2), and 3rd (D3) days after surgery. A CAM score > 19 is defined as POD. Secondary Outcomes: 1. The gender, age (years), weight (kg), ASA grade, comorbidities, preoperative simple mental state score, preoperative diagnosis, operation name, time from admission to surgery, duration of surgery (min), duration of PACU (min), blood transfusion, autologous blood, and the number and dose of additional local anesthetic during surgery were recorded. 2. Preoperative and postoperative C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). 3. The heart rate values of the four groups were rested for 5 min (T0), before fascia iliaca block (T1), 30 min after fascia iliaca block (T2), before neuraxial block (T3), after neuraxial block (T4), during surgical incision (T5), 20 min after surgical incision (T6), when transferred out of the operating room (T7), and after leaving the recovery room (T8). 4. VAS of T1, PACU, D1, D2, incidence of insomnia on the day of preoperative, on the day of surgery, D1 and D2. 5. Number of cases of perioperative adverse reactions (including nausea, vomiting, hypotension, hypertension and nerve block-related complications) (local anesthetic toxicity, nerve injury, local hematoma and infection). 6. The number of cases requiring salvage analgesics within 24 hours after the block.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-02-26 08:27:17
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