NCT06587711尚未招募不适用
Application of Cheek Acupuncture in Vaginal Tightening Surgery
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraoperative opioid consumption
研究概览
简要总结
A large number of studies have shown that acupuncture can reduce perioperative pain in patients. Cheek acupuncture therapy is a new acupuncture treatment, which belongs to the microneedle system, that is, acupuncture at specific acupoint on the face, which can relieve patients' pain. In this study, the efficacy and safety of cheek acupuncture in patients undergoing vaginal tightening surgery was verified by observing the consumption of opioid, intraoperative hemodynamics, dosage of oral remedial analgesics, postoperative quality of recovery, patient satisfaction, incidence of side effects, etc.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 years, undergoing vaginal tightening surgery
- •American Society of Anesthesiologists (ASA) physical status I to II
- •Voluntary participation and signed an informed consent form
排除标准
- •Acute and/or chronic pain before surgery
- •History of congenital heart disease, arrhythmia, or hypertension
- •History of severe mental or neurological diseases, drug or psychotropic drug abuse
- •Cognitive dysfunction or inability to communicate.
- •The acupuncture acupoints are infected
- •Coagulation disorders
- •Patients with mandibular or zygomatic bone osteotomy
结局指标
主要结局
Intraoperative opioid consumption
时间窗: End of surgery
Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption
次要结局
- Patient intravenous controlled analgesia (PCIA) pump consumption(24 hours after surgery)
- the rest numerical rating scale (NRS) scores(24 hours after surgery, 48 hours after surgery)
- the coughing numerical rating scale (NRS) scores(24 hours after surgery, 48 hours after surgery)
- 15-item quality of recovery (QoR-15)(1 day after surgery, 2 day after surgery)
- Systolic blood pressure (SBP)(Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery)
- Athens Insomnia Scale (AIS)(24 hours after surgery, 48 hours after surgery)
- Hospital Anxiety and Depression Scale（HADS）(24 hours after surgery, 48 hours after surgery)
- Patient satisfaction(48 hours after surgery)
- Diastolic blood pressure (DBP)(Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery)
- Mean blood pressure (MBP)(Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery)
- Heart rate (HR)(Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery)
- Opioid-related side effects(0~48 hours after surgery)
- Acupuncture-related side effects(0~48 hours after surgery)
- Intraoperative dexmedetomidine consumption(End of surgery)
- Intraoperative midazolam consumption(End of surgery)
- Respiratory rates (RR)(Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery)
- the partial pressure of end-tidal carbon dioxide (PetCO2)(Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery)
研究者
Chunmei Chen
Attending physician
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
研究点 (1)
Loading locations...
相似试验
已完成
不适用
'Acupuncture Therapy' for Pain and Function Recovery in Spine Surgery PatientsPainLow Back 'Spine Fusion' SurgeryNCT01304979Beth Israel Medical Center114
已完成
不适用
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With HypertensionSleep Apnea, ObstructiveNCT02451241University of Pernambuco44
招募中
不适用
Benefit of Acupuncture Combined to Regional Analgesia for Post Operative Pain Relief After HysterectomyPain, PostoperativeNCT06002464Vinmec Healthcare System72
进行中（未招募）
不适用
Acupuncture for the Management of Postoperative Pain in Patients With Pancreatic or Colorectal Cancer Undergoing SurgeryResectable Colorectal CarcinomaResectable Digestive System CarcinomaResectable Pancreatic CarcinomaNCT04560712M.D. Anderson Cancer Center70
已完成
2 期
Acupuncture for complementary pain relief following tonsillectomy in childretonsillectomyAnaesthesiology - Pain managementOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12619000922178Dr David Ho251