Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on EC50 of Remifentanil Inhibiting Cardiovascular Response After Tracheal Intubation Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the half maximum effective concentration (EC50) of remifentanil
研究概览
简要总结
During endotracheal tube insertion under general anesthesia, sympathetic nerve activity increases, which leads to increased heart rate, increased blood pressure, and increased catecholamine levels in the blood. It is important for patients to maintain hemodynamic stability during anesthesia induction and ultimately mitigate the cardiovascular stress response associated with tracheal intubation.
Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory (TENS-WAA) is a non-invasive pain treatment method, It has the advantages of easy wearing, concentrated treatment site, safe treatment and needle-free. To date, due to the lack of large-scale clinical use of TENS-WAA, only a few studies have reported the use of TENS-WAA for postoperative pain rehabilitation, especially for perioperative pain management. The aim of this study is to evaluate the median effective dose (ED50) of TENS-WAA for remifentanil inhibiting responses to tracheal intubation under general anesthesia, and to provide a reliable basis for its clinical promotion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-64 years old;
- •ASA grade I-Ⅲ;
- •BMI≤30kg/m2.
排除标准
- •Patients predicted to have difficult airways or those experiencing unsuccessful intubation processes;
- •Individuals with psychiatric disorders, cognitive impairments, or other conditions that preclude cooperation;
- •Patients who have received acupuncture treatment within the past three months or are undergoing routine acupuncture therapy;
- •Individuals with a history of severe cardiovascular disease, hyperthyroidism, or asthma;
- •Patients with contraindications to transcutaneous electrical nerve stimulation (TENS), including those with pacemakers, metallic implants, allergies to surface electrodes, skin sensory disorders, skin lesions, scars, or unhealed adhesions.
研究组 & 干预措施
T group
Patients received TENS-WAA with current stimulation
干预措施: TENS-WAA (Other)
C group
Patients received TENS-WAA without current stimulation
结局指标
主要结局
the half maximum effective concentration (EC50) of remifentanil
时间窗: The remifentanil concentration was recorded for 2 minutes after successful tracheal intubation.
Dixon's up-and-down method was used to determine the remifentanil concentration, starting from 3.0 ng/mL (step size of 0.2 ng/mL). After obtaining 7 infection points from positive to negative endotracheal intubation reactions, patient recruitment was terminated. A positive response to endotracheal intubation was defned as MAP 15% above the basal level or HR 15% above the basal level within 2 min of endotracheal intubation. The EC50 of remifentanil Ce was determined by calculating the average of the midpoint dose of all independent pairs of patients after six crossover points were obtained.
the half maximum effective concentration (EC50) of remifentanil
时间窗: The remifentanil concentration was recorded for 2 minutes after successful tracheal intubation.
Dixon's up-and-down method was used to determine the remifentanil concentration, starting from 3.0 ng/mL (step size of 0.2 ng/mL). After obtaining 7 infection points from positive to negative endotracheal intubation reactions, patient recruitment was terminated. A positive response to endotracheal intubation was defned as MAP 15% above the basal level or HR 15% above the basal level within 2 min of endotracheal intubation. The EC50 of remifentanil Ce was determined by calculating the average of the midpoint dose of all independent pairs of patients after six crossover points were obtained.
次要结局
- The dynamic VAS score(24 hour after surgery)
- QoR-15 questionnaire(24 hour after surgery)
- Postoperative airway complications(24 hour after surgery)
- Postoperative static pain (pain at rest)(24 hour after surgery)
- The time required for tracheal intubation(The time consumed by this procedure was recorded from the beginning of intubation until completion of inflation of the endotracheal tube cuff)
- Nausea and vomiting(24 hour after surgery)
研究者
Jia-feng Wang
Associate Chief Doctor
Changhai Hospital