Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- The incidence of Postoperative Sleep Disorders as Assessed by sleep monitoring screening device (ZG-S01D) and The The Athens Insomnia Scale
研究概览
简要总结
The goal of this clinical trial is to to explore the effect of perioperative transcutaneous acupoint acupuncture and moxibustion stimulation on sleep quality and postoperative chronic pain in patients undergoing thoracoscopic assisted radical resection of lung cancer, and explore its potential mechanism. This clinical trial focus on the following questions:
Whether perioperative transcutaneous acupoint acupuncture and moxibustion stimulation reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain ? What medical problems do participants have when taking acupuncture? Researchers will compare acupuncture to sham acupuncture (Non transdermal comfort needles can cause patients to experience a needle like sensation; similar to when the needle is inserted into the skin, but in reality, it does not break the skin) to see if acupuncture works to reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain.
Participants will:
Take acupuncture or a sham acupuncture every day for 3 days(the night before surgery, the night of surgery and the first night after surgery).
On the day before surgery, the first day after surgery, the second day after surgery, and the day before discharge, the sleep status should be continuously monitored using a sleep monitoring screening device (ZG-S01D) The incidence of pain is determined by whether there is pain (including all discomfort) during patient follow-up.
详细描述
This experiment is divided into two groups: the experimental group and the control group. If you participate in the experiment, you will be randomly assigned to two groups, with a 50% probability of entering the experimental group and a 50% probability of entering the control group.
Research steps Anesthesia process i. Preoperative preparation Complete the scoring form, continuous dynamic blood pressure monitoring, and continuous electrocardiogram monitoring 24 hours before surgery. All patients were fasted and deprived of water for 8 hours before surgery. The upper limb venous access was opened in the pre anesthesia room. Bupivacaine liposomes were used to block the intercostal nerves in 4 intercostal spaces above and below the incision, and invasive anesthesia was performed around the surgical incision and drainage tube placement. Supplement sodium lactate Ringer solution according to the preoperative loss amount. Confirm the informed consent status again.
After entering the room, routine electrocardiographic monitoring (ECG), non-invasive arterial blood pressure (NIBP), oxygen saturation (SpO2), and mask oxygen inhalation were performed.
ii. Anesthesia induction and maintenance Anesthesia induction: Inject sufentanil 0.4ug/kg and propofol 1.5-2mg/ml intravenously in sequence. After the patient's consciousness disappears, inject rocuronium 0.6mg/kg intravenously, insert a double lumen bronchial tube (F35-37), and locate with a fiberoptic bronchoscope.
Anesthesia maintenance: maintained by inhalation of sevoflurane, intraoperative detection of end tidal sevoflurane MAC value, maintained at 1.0-1.2MAC; Administer sufentanil and rocuronium bromide intravenously as needed during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Using SPSS 25.0 software, random numbers from 001 to 316 were generated through a computer and randomly assigned in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. The group information is sealed in opaque envelopes numbered randomly. Qualified subjects will be randomly assigned numbers in descending order of enrollment, without skipping numbers. Before implementing acupuncture and moxibustion, the acupuncture and moxibustion shall open the envelope allocated with the corresponding random number of the subject and conduct acupuncture and moxibustion according to the grouping information in the envelope. However, there was no communication between the acupuncture and moxibustion and other researchers and study patients about this study. Patients, attending anesthesiologists, surgeons, and data collectors (doctors responsible for evaluating sleep variables in the sleep laboratory) are all unaware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case selection: Patients undergoing elective thoracoscopic assisted radical resection for lung cancer, ASA grade I-II, aged 18-75 years.
- •Inclusion criteria:
- •Hospitalized patients aged ≥ 18 years old;
- •The surgical method is non emergency thoracoscopic assisted radical resection of lung cancer;
- •Patients with normal mental state, able to understand NRS scores, and correctly assess the degree of pain;
- •Patients who are informed and agree to the research objectives as explained.
- •Body Mass Index (BMI) 18.5-28 kg/m2
- •Preoperative clinical tumor lymph node metastasis (TNM) staging: according to cTis-3N01M0 of AJCC/UICC 8th edition.
排除标准
- •Patients with critical preoperative conditions or inability to cooperate;
- •Patients with postoperative disease recurrence, chronic infection, reoperation, or death;
- •Patients with severe complications, critical illness, or inability to cooperate after surgery;
- •Pittsburgh Sleep Quality Index (PSQI) score ≥ 7 or Insomnia Diagnosis - Ashens Insomnia Scale (AIS) score ≥ 6;
- •Sleep apnea or moderate or severe snoring;
- •In situ pacemaker, preoperative sinus bradycardia (heart rate ≤ 50 beats/minute) or sinoatrial node disease, second or third degree atrioventricular block
- •Long term use of anticonvulsants, antidepressants, or other psychotropic drugs
- •Severely sensitive or allergic to the drugs or devices in this study
- •Severe heart, liver, or kidney disease;
- •Participated in other clinical trials within the past 3 months;
- •h) Listening and/or language communication barriers; i) Pregnancy or breastfeeding; j) Clinical (hematological, radiological, and/or microbiological) evidence of fever (body temperature 38.5 ℃) or preoperative infection.
结局指标
主要结局
The incidence of Postoperative Sleep Disorders as Assessed by sleep monitoring screening device (ZG-S01D) and The The Athens Insomnia Scale
时间窗: From enrollment to the end of treatment at 1 week;
The Athens Insomnia Scale (AIS) is a self-assessment scale designed based on the ICD-10 diagnostic criteria for insomnia. There are a total of 8 questions, with the first 5 questions evaluating nighttime sleep and the last 3 questions evaluating daytime function. The scoring range for each question is 0-3, with a total score of 24 points. A score greater than or equal to 6 indicates the presence of sleep disorders. AIS is suitable for evaluating sleep status in the past month.
次要结局
未报告次要终点
研究者
LIna Huang
Chief Physician of Anesthesiology Department, Shanghai General Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine