ChiCTR2600126594 版本V1.0 版本创建时间2026/06/11 17:40:02 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600126594 

最近更新日期：

Date of Last Refreshed on：

 2026-06-11 17:39:56 

注册时间：

Date of Registration：

 2026-06-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

羟考酮与舒芬太尼预防经尿道前列腺切除术后导尿管相关膀胱不适的效果比较：一项随机、双盲、平行对照试验

Public title：

Comparison of Oxycodone and Sufentanil for Preventing Catheter-Related Bladder Discomfort After Transurethral Resection of the Prostate: A Randomized, Double-Blind, Parallel-Group Controlled Trial

注册题目简写：

羟考酮减轻CRBD

English Acronym：

Oxycodone reduces CRBD

研究课题的正式科学名称：

羟考酮与舒芬太尼预防经尿道前列腺切除术后导尿管相关膀胱不适的效果比较：一项随机、双盲、平行对照试验

Scientific title：

Comparison of Oxycodone and Sufentanil for Preventing Catheter-Related Bladder Discomfort After Transurethral Resection of the Prostate: A Randomized, Double-Blind, Parallel-Group 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：

王良荣 

研究负责人：

王良荣 

Applicant：

Liangrong Wang 

Study leader：

Wang Liangrong 

申请注册联系人电话：

Applicant telephone：

 +86 577 8668 9476

研究负责人电话：

Study leader's
telephone：

+86 135 8788 4540

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：

 arerong1984@126.com

研究负责人电子邮件：

Study leader's E-mail：

 arerong@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：

浙江省温州市瓯海区南白象街道上蔡村

研究负责人通讯地址：

浙江省温州市瓯海区温州医科大学附属第一医院南白象院区

Applicant address：

Shangcai Villiage, Ouhai District, Wenzhou City, Zhejiang Province

Study leader's address：

The First Affiliated Hospital of Wenzhou Medical University Nanbaixiang Wenzhou

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：

温州医科大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Wenzhou Medical University

研究负责人所在单位：

温州医科大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Wenzhou Medical University

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：

 临床研究伦审IssuingNumber(2026)第(183)号

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：

温州医科大学附属第一医院临床研究伦理委员会

Name of the ethic committee：

Ethics Committee in Clinical Research (ECCR) of the First Affiliated Hospital of Wenzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-04 00:00:00

伦理委员会联系人：

黄胜威

Contact Name of the ethic committee：

Shengwei Huang

伦理委员会联系地址：

浙江省温州市瓯海区温州医科大学附属第一医院南白象院区

Contact Address of the ethic committee：

The First Affiliated Hospital of Wenzhou Medical University Nanbaixiang Wenzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 577 5557 8056

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 huangsw58@163.com

研究实施负责（组长）单位：

温州医科大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Wenzhou Medical University

研究实施负责（组长）单位地址：

浙江省温州市瓯海区温州医科大学附属第一医院南白象院区

Primary sponsor's address：

The First Affiliated Hospital of Wenzhou Medical University Nanbaixiang Wenzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

温州医科大学附属第一医院

具体地址：

浙江省温州市瓯海区温州医科大学附属第一医院南白象院区

Institution
hospital：

The First Affiliated Hospital of Wenzhou Medical University

Address：

The First Affiliated Hospital of Wenzhou Medical University Nanbaixiang Wenzhou

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-raised

研究疾病：

前列腺增生；导尿管相关膀胱不适  

Target disease：

Benign Prostatic Hyperplasia; Catheter-Related Bladder Discomfort

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟通过前瞻性随机对照临床试验，以舒芬太尼为对照，探讨羟考酮替代舒芬太尼用于经尿道前列腺切除手术全身麻醉的可行性及优越性，具体目标包括： 1. 明确羟考酮替代舒芬太尼对经尿道前列腺切除手术后CRBD发生率及严重程度的影响，验证基于kappa受体多靶点调控机制的替代策略在CRBD预防中的临床优越性。 2. 评估该替代方案在围术期的麻醉效能（包括镇静镇痛深度、血流动力学稳定性）及安全性，重点关注术后恶心呕吐、呼吸抑制及过度镇静等阿片类药物相关不良反应的发生情况。 3. 为经尿道前列腺切除手术围术期麻醉用药策略的优化提供循证医学依据，推动确立羟考酮在该术式中的精准应用模式，拓展其基于kappa受体机制的临床应用场景。  

Objectives of Study：

This study aims to investigate the feasibility and superiority of using oxycodone as an alternative to sufentanil for general anesthesia in transurethral prostate resection surgery through a prospective, randomized controlled clinical trial with sufentanil as the control. The specific objectives are as follows: 1. To determine the effect of substituting oxycodone for sufentanil on the incidence and severity of catheter-related bladder discomfort (CRBD) following transurethral prostate resection surgery, and to validate the clinical superiority of this substitution strategy—based on a multi-target regulatory mechanism involving the kappa-opioid receptor—in the prevention of CRBD. 2. To evaluate the perioperative anesthetic efficacy (including depth of sedation and analgesia, and hemodynamic stability) and safety of this alternative regimen, with a focus on the occurrence of opioid-related adverse effects such as postoperative nausea and vomiting, respiratory depression, and excessive sedation. 3. To provide evidence-based medical support for optimizing perioperative anesthesia strategies in transurethral prostate resection surgery, thereby facilitating the establishment of a precise application model for oxycodone in this surgical procedure and expanding its clinical use based on kappa-opioid receptor mechanisms.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.拟在全身麻醉下择期行经尿道前列腺电切术（TURP）或钬激光前列腺切除术（HoLEP）的男性患者；
2.年龄50-75岁；
3.患者身体质量指数（BMI）18-28 kg/m2；
4.美国麻醉医师协会（ASA）分级I-II级；
5.术后留置F20三腔导尿管；

Inclusion criteria

1.Male patients scheduled for elective transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP) under general anesthesia;
2.Aged 50–75 years;
3.Body mass index (BMI) between 18 and 28 kg/m2;
4.American Society of Anesthesiologists (ASA) physical status classification I or II;
5.Postoperative indwelling of a F20 three-way urinary catheter;

排除标准：

1.对羟考酮或舒芬太尼过敏者；
2.术前24 h内使用过抗胆碱能药物、抗组胺药或镇静药者；
3.患有严重心血管、呼吸系统疾病或肝肾功能障碍者；
4.有慢性疼痛病史或长期阿片类药物使用史者；
5.伴发影响膀胱功能或感觉的神经系统疾病（如多发性硬化、脊髓损伤）等病史；
6.术前即存在膀胱过度活动症、神经源性膀胱、急慢性尿路感染者；
7.既往接受过阴茎或前列腺手术；
8.去3个月内接受过导尿术或导尿管留置状态；
9.预计手术时间< 30 min或超过2 h或需要转为开放手术者；
10.拒绝参与研究；

Exclusion criteria：

1.Allergy to oxycodone or sufentanil;
2.Use of anticholinergics, antihistamines, or sedatives within 24 hours before surgery;
3.Severe cardiovascular or respiratory disease, or hepatic or renal dysfunction;
4.History of chronic pain or long-term opioid use;
5.Concomitant neurological diseases affecting bladder function or sensation (e.g., multiple sclerosis, spinal cord injury);
6.Pre-existing overactive bladder, neurogenic bladder, or acute/chronic urinary tract infection before surgery;
7.Previous penile or prostate surgery;
8.History of urinary catheterization or indwelling catheter within the past 3 months;
9.Expected surgery duration < 30 minutes or > 2 hours, or anticipated conversion to open surgery;
10.Refusal to participate in the study;

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2029-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-15 00:00:00 至 To 2027-11-30 00:00:00

干预措施：

Interventions：

组别：

羟考酮组

样本量：

 78

Group：

Oxycodone group

Sample size：

干预措施：

麻醉诱导和维持以羟考酮作为麻醉性镇痛药

干预措施代码：

Intervention：

Oxycodone was used as the opioid for both anesthesia induction and maintenance

Intervention code：

组别：

舒芬太尼组

样本量：

 78

Group：

Sufentanil group

Sample size：

干预措施：

麻醉诱导和维持以舒芬太尼作为麻醉性镇痛药

干预措施代码：

Intervention：

Sufentanil was used as the opioid for both anesthesia induction and maintenance

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 温州医科大学附属第一医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Wenzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

镇痛补救治疗情况

指标类型：

次要指标

Outcome：

Analgesic rescue treatment

Type：

Secondary indicator

测量时间点：

术后0-6 h期间

测量方法：

当VAS评分≥4分时，予氟比洛芬酯1 mg/kg静脉注射作为补救镇痛药物。记录术后0-6 h期间镇痛补救药物的使用次数及总剂量

Measure time point of outcome：

Within the first 6 hours after surgery

Measure method：

When the VAS score reached >= 4, flurbiprofen axetil 1 mg/kg was administered intravenously as a rescue analgesic. The frequency of rescue analgesic administration and the total dose administered during the 0–6 h postoperative period were recorded.

指标中文名：

CRBD补救治疗情况

指标类型：

次要指标

Outcome：

Rescue treatment for CRBD

Type：

Secondary indicator

测量时间点：

术后0-6 h期间

测量方法：

当CRBD严重程度评分达到中重度（≥2分）时，予曲马多1.5 mg/kg静脉注射作为补救药物。记录术后0-6 h期间CRBD补救药物的使用次数及总剂量

Measure time point of outcome：

Within the first 6 hours after surgery

Measure method：

When the CRBD severity score reached moderate-to-severe level ( >= 2 points), tramadol 1.5 mg/kg was administered intravenously as a rescue medication. The frequency of rescue medication use and the total dose of tramadol administered during the 0–6 h postoperative period were recorded.

指标中文名：

其他不良事件

指标类型：

次要指标

Outcome：

Other adverse events

Type：

Secondary indicator

测量时间点：

术后0-6 h期间

测量方法：

记录术后6 h内头晕、头痛、口干和寒战发生情况

Measure time point of outcome：

Within the first 6 hours after surgery

Measure method：

The occurrence of dizziness, headache, dry mouth, and shivering within 6 hours after surgery was recorded.

指标中文名：

镇静过度

指标类型：

次要指标

Outcome：

Excessive sedation

Type：

Secondary indicator

测量时间点：

术后0-6 h期间

测量方法：

记录术后6 h内镇静过度（RASS评分≤-3分）的发生情况

Measure time point of outcome：

Within the first 6 hours after surgery

Measure method：

The occurrence of excessive sedation (RASS score ≤ -3) within 6 hours after surgery was recorded.

指标中文名：

各时点中重度CRBD发生率

指标类型：

次要指标

Outcome：

Incidence of moderate-to-severe CRBD at each time point

Type：

Secondary indicator

测量时间点：

术后0、1、2、6 h

测量方法：

记录术后即刻（0 h）及术后1、2、6 h时发生中重度CRBD的患者比例

Measure time point of outcome：

Immediately after surgery (0 h) and at 1, 2, and 6 h postoperatively

Measure method：

The proportion of patients who developed moderate-to-severe CRBD immediately after surgery (0 h) and at 1, 2, and 6 h postoperatively was recorded.

指标中文名：

术后6 h内中重度CRBD发生率

指标类型：

主要指标

Outcome：

Incidence of moderate-to-severe CRBD within 6 hours postoperatively

Type：

Primary indicator

测量时间点：

术后6 h内

测量方法：

记录术后0-6 h期间至少发生一次中重度CRBD（CRBD严重程度评分≥2分）的患者所占比例

Measure time point of outcome：

Within 6 hours postoperatively

Measure method：

The proportion of patients who experienced at least one episode of moderate-to-severe CRBD (CRBD severity score >= 2) during the 0–6 h postoperative period

指标中文名：

苏醒期躁动

指标类型：

次要指标

Outcome：

Emergence agitation

Type：

Secondary indicator

测量时间点：

苏醒期

测量方法：

记录苏醒期躁动（RASS评分≥2分）的发生情况

Measure time point of outcome：

During emergence period

Measure method：

The occurrence of emergence agitation (RASS score >= 2) was recorded.

指标中文名：

各时点CRBD总发生率

指标类型：

次要指标

Outcome：

Overall incidence of CRBD at each time point

Type：

Secondary indicator

测量时间点：

术后即刻（0 h）及术后1、2、6 h

测量方法：

CRBD总体发生率定义为各时点评估中CRBD严重程度评分≥1分的患者所占比例（即轻度、中度及重度CRBD患者的总和）。分别计算术后即刻、1 h、2 h及6 h时点的CRBD总体发生率。

Measure time point of outcome：

Immediately after surgery (0 h) and at 1, 2, and 6 h postoperatively

Measure method：

Overall incidence of CRBD was defined as the proportion of patients with a CRBD severity score >= 1 (i.e., the sum of mild, moderate, and severe CRBD cases) at each time point. The overall incidence of CRBD was calculated separately for the immediate postoperative period (0 h) and at 1 h, 2 h, and 6 h postoperatively.

指标中文名：

呼吸抑制

指标类型：

次要指标

Outcome：

Respiratory depression

Type：

Secondary indicator

测量时间点：

术后0-6 h期间

测量方法：

记录术后6 h内呼吸抑制（呼吸频率<8次/min和/或SpO2<90%）发生情况

Measure time point of outcome：

Within the first 6 hours after surgery

Measure method：

The occurrence of respiratory depression (respiratory rate < 8 breaths/min and/or SpO? < 90%) within 6 hours after surgery was recorded.

指标中文名：

术后疼痛程度

指标类型：

次要指标

Outcome：

Postoperative pain severity

Type：

Secondary indicator

测量时间点：

术后0、1、2、6 h

测量方法：

采用视觉模拟评分评估术后0、1、2、6 h时的疼痛强度（VAS，0分=无痛，10分=剧痛）

Measure time point of outcome：

Immediately after surgery (0 h) and at 1, 2, and 6 h postoperatively

Measure method：

Pain intensity was assessed using a Visual Analog Scale (VAS) at 0, 1, 2, and 6 h postoperatively, where 0 represented no pain and 10 represented the most severe pain.

指标中文名：

患者满意度评分

指标类型：

次要指标

Outcome：

Patient satisfaction score

Type：

Secondary indicator

测量时间点：

术后6 h时

测量方法：

术后6 h时采用11分制Likert满意度量表进行评估，0-2分表示完全不满意，3-4分表示不满意，5-6分表示中立，7-8分表示满意，9-10分表示完全满意。

Measure time point of outcome：

At 6 h postoperatively

Measure method：

Patient satisfaction was assessed 6 hours postoperatively using an 11-point Likert scale, where scores of 0–2 indicated complete dissatisfaction, 3–4 indicated dissatisfaction, 5–6 indicated neutrality, 7–8 indicated satisfaction, and 9–10 indicated complete satisfaction.

指标中文名：

术后恶心呕吐

指标类型：

次要指标

Outcome：

Postoperative nausea and vomiting

Type：

Secondary indicator

测量时间点：

术后0-6 h期间

测量方法：

记录术后6 h内恶心、干呕或呕吐的发生情况，当恶心呕吐评分达3分及以上，予甲氧氯普胺10mg肌注，记录镇吐补救时间和例次

Measure time point of outcome：

Within the first 6 hours after surgery

Measure method：

The occurrence of nausea, retching, or vomiting within 6 hours after surgery was recorded. When the nausea and vomiting score reached 3 or higher, metoclopramide 10 mg was administered intramuscularly as rescue antiemetic therapy. The time to rescue antiemetic administration and the number of rescue episodes were recorded.

指标中文名：

CRBD严重程度评分

指标类型：

次要指标

Outcome：

CRBD Severity Score

Type：

Secondary indicator

测量时间点：

术后0、1、2、6 h

测量方法：

采用4分量表评估术后0、1、2、6 h时的CRBD严重程度（0分=无不适；1分=轻度，仅在询问时提及；2分=中度，主动主诉并伴有烦躁；3分=重度，出现喊叫或试图拔除导管等行为）

Measure time point of outcome：

Immediately after surgery (0 h) and at 1, 2, and 6 h postoperatively

Measure method：

A 4-point scale was used to assess the severity of CRBD at 0, 1, 2, and 6 h postoperatively (0 = no discomfort; 1 = mild, reported only when asked; 2 = moderate, spontaneously complained with restlessness; 3 = severe, with behaviors such as crying out or attempting to remove the catheter).

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 50 岁 years
最大 Max age 75 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

采用区组随机化方法。由不参与临床麻醉和数据收集的研究人员，使用计算机生成的随机数字表将患者按1:1比例分配至羟考酮组和舒芬太尼组。

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

A block randomization method was used. Patients were assigned in a 1:1 ratio to either the oxycodone group or the sufentanil group by a researcher who was not involved in clinical anesthesia or data collection, using a computer-generated random number table.

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：

双盲

Blinding：

Double blind

是否共享原始数据：

IPD sharing

是Yes

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）：

我们将共享本文结果所依据的去隐私化个体参与者数据，包括文本、表格、图表及附录。

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

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

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：

采用纸质病例报告表（CRF）由盲态评估人员于响应时间点采集数据。CRF经双人独立录入、第三方核对，电子数据存储于加密服务器。每位患者分配唯一研究编号，确保隐私保密。去隐私化数据可在发表后向研究者申请共享。

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

Data will be collected using paper Case Report Forms (CRFs) by blinded assessors at the designated time points. CRF data will be double-entered independently and cross-verified by a third party. Electronic data will be stored on a password-protected encrypted server. Each patient will be assigned a unique study identification number to protect personal privacy. De-identified individual participant data will be made available to researchers upon reasonable request following publication.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-11 17:39:56