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一氧化二氮吸入联合利多卡因局部麻醉对于整形外科门诊手术舒适度的影响
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注册号：

Registration number：

 ChiCTR2400080612 

最近更新日期：

Date of Last Refreshed on：

 2024-02-02 15:13:37 

注册时间：

Date of Registration：

 2024-02-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一氧化二氮吸入联合利多卡因局部麻醉对于整形外科门诊手术舒适度的影响

Public title：

Effect of nitrous oxide inhalation combined with lidocaine local anesthesia on the comfort level of outpatient plastic surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一氧化二氮吸入联合利多卡因局部麻醉对于整形外科门诊手术舒适度的影响

Scientific title：

Effect of nitrous oxide inhalation combined with lidocaine local anesthesia on the comfort level of outpatient plastic surgery

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：

苏伊丹 

研究负责人：

董子迎 

Applicant：

Yidan Su 

Study leader：

Ziying Dong 

申请注册联系人电话：

Applicant telephone：

 +86 176 2188 0686

研究负责人电话：

Study leader's
telephone：

+86 175 6168 7800

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：

 suyidan88@126.com

研究负责人电子邮件：

Study leader's E-mail：

 dzy0633@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：

青岛市市北区胶州路1号

研究负责人通讯地址：

青岛市市北区胶州路1号

Applicant address：

No. 1 Jiaozhou Road, Shibei District, Qingdao

Study leader's address：

No. 1 Jiaozhou Road, Shibei District, Qingdao

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：

青岛市市立医院

Applicant's institution：

Qingdao Municipal Hospital

研究负责人所在单位：

青岛市市立医院

Affiliation of the Leader：

Qingdao Municipal 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：

 2023-KY-068

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：

青岛市市立医院医学伦理委员会

Name of the ethic committee：

Qingdao Municipal Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-01-04 00:00:00

伦理委员会联系人：

朱蕾

Contact Name of the ethic committee：

Lei Zhu

伦理委员会联系地址：

青岛市市北区胶州路1号

Contact Address of the ethic committee：

No. 1 Jiaozhou Road, Shibei District, Qingdao

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 532 8278 9053

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

青岛市市立医院

Primary sponsor：

Qingdao Municipal Hospital

研究实施负责（组长）单位地址：

青岛市市北区胶州路1号

Primary sponsor's address：

No. 1 Jiaozhou Road, Shibei District, Qingdao

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东

市(区县)：

青岛

Country：

China

Province：

Shandong

City：

Qingdao

单位(医院)：

青岛市市立医院

具体地址：

青岛市市北区胶州路1号

Institution
hospital：

Qingdao Municipal Hospital

Address：

No. 1 Jiaozhou Road, Shibei District, Qingdao

经费或物资来源：

暂无

Source(s) of funding：

None

研究疾病：

无  

Target disease：

None

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：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.探究一氧化二氮吸入联合利多卡因局部麻醉对整形外科门诊手术镇痛效果的影响。 2.对比一氧化二氮吸入联合利多卡因局部麻醉与单纯利多卡因局部麻醉在术中患者血压、心率等各指标的差别。 3.分析整形外科门诊手术中应用一氧化二氮吸入联合利多卡因局部麻醉的有效性及安全性。  

Objectives of Study：

1. To explore the influence of nitrous oxide inhalation combined with lidocaine local anesthesia on the analgesic effect of plastic surgery outpatient surgery. 2. Compare the difference between nitrous oxide inhalation combined with lidocaine local anesthesia and lidocaine local anesthesia alone in blood pressure, heart rate and other indexes of patients during the operation. 3. To analyze the efficacy and safety of nitrous oxide inhalation combined with lidocaine local anesthesia in outpatient plastic surgery.

药物成份或治疗方案详述：

1. 纳入患者签署知情同意书后，完成术前评估量表，包括简易状态特质焦虑量表，记录患者疾病史、饮酒史等各项指标。由分组人员以单盲方式(患者被盲)将将纳入患者随机分为两组：A组（N20/O2）在手术麻醉前行一氧化二氮/氧气吸入，B组（Air/O2）行空气/氧气吸入，其后局麻及手术方式相同。 2. 术前准备完成后，与麻醉医生核对患者信息，核对有无麻醉吸入及手术禁忌症。 3. 患者平卧于手术床上，连接心电监护，检测心率、无创血压及血氧饱和度。休息五分钟后由麻醉医生操作吸入装置，经鼻导管给予患者一氧化二氮或空气，起始浓度为20%，之后每5分钟增加5%，直到最大浓度达到50%。在吸入50%一氧化二氮或空气约5分钟后予2%利多卡因和1:20万肾上腺素局部麻醉，随后开始手术操作。手术中始终关注患者意识及疼痛情况，确保患者意识清醒。 4. 气体吸入前，局麻注射时，手术操作中，停止吸入时四个时间点由助手记录患者心率、血压及血氧饱和度数值。由麻醉医生在四个时间点行镇静（Ramsay）评分及Frankl配合程度评分，记录在原始数据中。 5. 手术中由麻醉医生实时观察患者状态，如出现头晕、头痛、恶心、呕吐、腹胀、低血压、心律失常、躁动等不良反应应立即停止吸入一氧化二氮，并给予对症缓解措施，记录不良反应记录。出现误吸导致的支气管痉挛、窒息、肺炎、肺不张等严重不良事件应立即采取治疗措施，必要时气管插管处理。 6. 手术结束后立即停止吸入一氧化二氮，两组患者均经鼻导管给予纯氧10分钟。休息结束后完成术后评估。最主要结局通过数字疼痛评分法（VAS）手术过程中最大疼痛度。次要结局也由VAS评估，包括基线疼痛、预期疼痛、手术结束后5分钟的疼痛。再次通过简易状态特质焦虑量表评估患者焦虑情况。记录术后恶心、嗜睡和头晕等不良反应。术后观察半小时，由麻醉医生行PADS评分，评分≥9分可离院。 7. 在手术后的第1天和第3天对患者进行随访（可安排在患者换药时进行），主要记录患者可能出现的安全性指标，如头晕、头痛、恶心、呕吐、腹胀等。如出现不良反应，应及时对症处理，并将症状及处理方式记录在原始数据中。 

Description for medicine or protocol of treatment in detail：

1. After obtaining signed informed consent from the patients, preoperative assessment scales, including the Brief State-Trait Anxiety Inventory, were completed to record patients' medical and alcohol history, among other relevant parameters. The enrolled patients were then divided into two groups, A (N20/O2) and B (Air/O2), by the blinded study personnel (patients blinded). Group A received nitrous oxide/oxygen inhalation before anesthesia induction, while Group B received air/oxygen inhalation. Both groups underwent the same local anesthesia and surgical procedures. 2. After completing the preoperative preparations, the patient's information was verified with the anesthesiologist to confirm the absence of contraindications for anesthesia inhalation and surgery. 3. The patient was placed in a supine position on the operating table and connected to electrocardiographic monitoring to measure heart rate, non-invasive blood pressure, and oxygen saturation. Following a 5-minute rest period, the anesthesiologist initiated inhalation through a nasal cannula, administering nitrous oxide or air to the patient. The initial concentration was 20%, increased by 5% every 5 minutes until reaching a maximum concentration of 50%. Approximately 5 minutes after inhaling 50% nitrous oxide or air, local anesthesia with 2% lidocaine and 1:200,000 epinephrine was administered, followed by the commencement of the surgical procedure. Throughout the surgery, the patient's consciousness and pain levels were monitored to ensure they remained awake and responsive. 4. Four time points—before gas inhalation, during local anesthesia injection, during the surgical procedure, and after gas inhalation cessation—were recorded by the assistant to monitor the patient's heart rate, blood pressure, and oxygen saturation. The anesthesiologist assigned sedation (Ramsay) scores and evaluated cooperation levels using the Frankl scale at these time points, documenting them in the raw data. 5. The anesthesiologist continuously monitored the patient's condition during the surgery. In case of adverse reactions such as dizziness, headache, nausea, vomiting, abdominal distension, hypotension, arrhythmia, or restlessness, the administration of nitrous oxide was immediately discontinued, and appropriate measures were taken for symptomatic relief, with a record of any adverse reactions. Serious adverse events, such as bronchospasm, asphyxia, pneumonia, or atelectasis resulting from aspiration, required immediate treatment, including potentially intubating the patient's trachea if necessary. 6. Nitrous oxide inhalation was ceased immediately after the completion of surgery, and both groups received pure oxygen via nasal cannula for 10 minutes. After the rest period, postoperative assessment was conducted. The primary outcome measure was the maximum pain intensity during the surgery, assessed using the Visual Analog Scale (VAS). Secondary outcome measures assessed by the VAS included baseline pain, expected pain, and pain at 5 minutes after the completion of surgery. Patient anxiety levels were also evaluated using the Brief State-Trait Anxiety Inventory. Adverse reactions such as nausea, drowsiness, and dizziness after the surgery were documented. Postoperative observation lasted for 30 minutes, during which the anesthesiologist performed the Post-Anesthetic Discharge Scoring System (PADS) assessment. A score of ≥9 allowed for discharge. 7. Follow-up assessments were conducted on the first and third days following the surgery (which could be scheduled during dressing changes) to focus on recording potential safety indicators such as dizziness, headache, nausea, vomiting, and abdominal distension. Any adverse reactions that occurred were promptly managed, and both the symptoms and corresponding treatment methods were documented in the raw data. 

纳入标准：

Inclusion criteria

排除标准：

1.对本研究所使用药物过敏； 2.面部手术患者； 3.术前并发心、脑、肺、肝、肾等脏器功能障碍； 4.长期使用镇痛、镇静、精神类药物； 5. 孕妇； 6. 不能充分获得医疗史的患者。

Exclusion criteria：

1. Allergic to drugs used in this study; 2. Patients receiving facial surgery; 3. Dysfunction of heart, brain, lung, liver, kidney and other organs before surgery; 4. Long-term use of analgesic, sedative or psychotropic drugs; 5. Pregnant or lactating women; 6. Patients with inadequate access to medical history.

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2025-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-03-01 00:00:00 至 To 2024-06-01 00:00:00

干预措施：

Interventions：

组别：

实验组（A）

样本量：

 42

Group：

Experimental group

Sample size：

干预措施：

患者平卧于手术床上，连接心电监护，检测心率、无创血压及血氧饱和度。休息五分钟后由麻醉医生操作吸入装置，经鼻导管给予患者一氧化二氮，起始浓度为20%，之后每5分钟增加5%，直到最大浓度达到50%。在吸入50%一氧化二氮约5分钟后予2%利多卡因和1:20万肾上腺素局部麻醉，随后开始手术操作。

干预措施代码：

 A

Intervention：

The patient lies supine on the operating table, connected to electrocardiographic monitoring to detect heart rate, non-invasive blood pressure, and oxygen saturation. After resting for five minutes, the anesthesia doctor operates the inhalation device to administer nitrous oxide to the patient through a nasal cannula, starting at a concentration of 20% and increasing by 5% every 5 minutes until reaching a maximum concentration of 50%. Approximately 5 minutes after inhaling 50% nitrous oxide, the patient is given 2% lidocaine and 1:200,000 adrenaline for local anesthesia, followed by the commencement of the surgical procedure.

Intervention code：

组别：

对照组（B）

样本量：

 42

Group：

Control group

Sample size：

干预措施：

患者平卧于手术床上，连接心电监护，检测心率、无创血压及血氧饱和度。休息五分钟后由麻醉医生操作吸入装置，经鼻导管给予患者氧气，再次休息5分钟后予2%利多卡因和1:20万肾上腺素局部麻醉，随后开始手术操作。

干预措施代码：

 B

Intervention：

The patient lies supine on the operating table, connected to electrocardiographic monitoring to detect heart rate, non-invasive blood pressure, and oxygen saturation. After resting for five minutes, the anesthesia doctor operates the inhalation device to administer oxygen to the patient through a nasal cannula. After a further 5 minutes of rest, the patient is given 2% lidocaine and 1:200,000 adrenaline for local anesthesia, following which the surgical procedure commences.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

 青岛 

Country：

China

Province：

Shandong

City：

Qingdao

单位(医院)：

 青岛市市立医院 

单位级别：

 三级甲等 

Institution
hospital：

Qingdao Municipal Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

疼痛度

指标类型：

主要指标

Outcome：

Pain

Type：

Primary indicator

测量时间点：

术后

测量方法：

数字疼痛评分法

Measure time point of outcome：

Postoperation

Measure method：

Visual Pain Scoring

指标中文名：

血压

指标类型：

主要指标

Outcome：

Blood pressure

Type：

Primary indicator

测量时间点：

四个时间点：气体吸入前，局麻注射时，手术操作中，停止吸入时四个时间点

测量方法：

心电监护仪测量

Measure time point of outcome：

Four time points: before inhalation of gas, during local anesthesia injection, during the surgical procedure, and when inhalation is stopped.

Measure method：

Ecg monitor measurement

指标中文名：

心率

指标类型：

主要指标

Outcome：

Heart rate

Type：

Primary indicator

测量时间点：

四个时间点：气体吸入前，局麻注射时，手术操作中，停止吸入时四个时间点

测量方法：

心电监护仪测量

Measure time point of outcome：

Four time points: before inhalation of gas, during local anesthesia injection, during the surgical procedure, and when inhalation is stopped.

Measure method：

Ecg monitor measurement

指标中文名：

血氧饱和度

指标类型：

次要指标

Outcome：

Blood oxygen saturation

Type：

Secondary indicator

测量时间点：

四个时间点：气体吸入前，局麻注射时，手术操作中，停止吸入时四个时间点

测量方法：

心电监护仪测量

Measure time point of outcome：

Four time points: before inhalation of gas, during local anesthesia injection, during the surgical procedure, and when inhalation is stopped.

Measure method：

Ecg monitor measurement

指标中文名：

不良反应

指标类型：

副作用指标

Outcome：

Adverse reaction

Type：

Adverse events

测量时间点：

术中及术后

测量方法：

观察及询问患者症状

Measure time point of outcome：

During and after surgery

Measure method：

Observe and ask the patient for symptoms

指标中文名：

焦虑指数

指标类型：

次要指标

Outcome：

Index of anxiety

Type：

Secondary indicator

测量时间点：

术前及术后

测量方法：

简易状态特质焦虑量表

Measure time point of outcome：

Preoperative and postoperative

Measure method：

Simple state trait Anxiety Scale

指标中文名：

镇静评分

指标类型：

次要指标

Outcome：

Ramsay score

Type：

Secondary indicator

测量时间点：

四个时间点：气体吸入前，局麻注射时，手术操作中，停止吸入时四个时间点

测量方法：

麻醉医生询问患者，根据患者回答进行评分

Measure time point of outcome：

Four time points: before inhalation of gas, during local anesthesia injection, during the surgical procedure, and when inhalation is stopped.

Measure method：

The anesthesiologist questions the patient and scores them based on their responses

指标中文名：

配合程度评分

指标类型：

次要指标

Outcome：

Frankl score

Type：

Secondary indicator

测量时间点：

四个时间点：气体吸入前，局麻注射时，手术操作中，停止吸入时四个时间点

测量方法：

麻醉医生询问患者，根据患者回答进行评分

Measure time point of outcome：

Four time points: before inhalation of gas, during local anesthesia injection, during the surgical procedure, and when inhalation is stopped.

Measure method：

The anesthesiologist questions the patient and scores them based on their responses

指标中文名：

麻醉后离院评分

指标类型：

附加指标

Outcome：

PADS score

Type：

Additional indicator

测量时间点：

术后30分钟

测量方法：

由麻醉医生根据患者状态进行评分

Measure time point of outcome：

30 minutes postoperative

Measure method：

Score by anesthesiologist according to patient status

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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 18 岁 years
最大 Max age 65 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）：

区组随机法，由专门的分组人员借助SAS统计软件PROC PLAN过程语句，给定种子数，产生随机安排。

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

Randomized block method, by the special grouping personnel with SAS statistical software PROC PLAN procedure statements, given the number of seeds, to generate random arrangements.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本试验为单盲，仅患者被盲。

Blinding：

This study was single blind, and only patients are blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

研究发表后在Resman网站分享原始数据（http://www.medresman.org.cn/pub/cn/proj/search.aspx）

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

The data will be shared on website after publication. http://www.medresman.org.cn/pub/cn/proj/search.aspx

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CRF表进行数据记录,后记录于ResMan网站（http://www.medresman.org.cn/login.aspx）

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

Data record with CRF, then record in website: http://www.medresman.org.cn/login.aspx.

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：

  2024-02-02 15:13:30
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