研究疾病:
|
术后睡眠障碍
|
研究疾病代码:
|
|
Target disease:
|
Postoperative Sleep Disturbances
|
Target disease code:
|
研究类型:
Study type:
|
干预性研究
Interventional study
|
研究设计:
Study design:
|
随机平行对照
randomized controlled trial(parallel group design)
|
研究所处阶段:
Study phase:
|
探索性研究/预试验
Pilot clinical trial
|
研究目的:
|
本研究旨在探讨术中应用右美托咪定联合经皮穴位电刺激(TEAS)是否可改善腹腔镜妇科手术患者术后的睡眠质量,找出改善术后睡眠的最佳干预措施。
|
Objectives of Study:
|
The purpose of this study was to explore whether the intraoperative application of dexmedetomidine combined with transcutaneous electrical acupoint stimulation (TEAS) can improve the postoperative sleep quality of patients with laparoscopic gynecological surgery, and to find the best intervention measures to improve postoperative sleep.
|
药物成份或治疗方案详述:
|
所有患者未用术前药物。入室后常规监测ECG、BP,NBP及SpO2。
1.TEAS(T) 组:麻醉诱导前30 min至术毕使用华佗牌SDZ-II型电子针疗仪经皮电刺激双侧足三里,三阴交及内关穴,2/100HZ的疏密波型,电流强度电6~15mA(以病人最大的耐受度为准)。麻醉诱导后至手术结束前40min以0.02~0.04ml/kg/h的速度维持泵注生理盐水。
2.右美(D)组:麻醉诱导前30 min在相同穴位贴电极片,电刺激参数同TEAS组,仅予以固定而不行电刺激。麻醉诱导后至手术结束前40min以0.2μg/kg/h~0.4μg/kg/h的速度维持泵注右美托咪定。
3.TEAS联合右美(TD)组:麻醉诱导前30 min至术毕使用华佗牌SDZ-II型电子针疗仪经皮电刺激双侧足三里,三阴交及内关穴,2/100HZ的疏密波型,电流强度电6~15mA(以病人最大的耐受度为准)。麻醉诱导后至手术结束前40min以0.2~0.4μg/kg/h的速度维持泵注右美托咪定。
4.空白对照(C)组:麻醉诱导前30 min在相同穴位贴电极片,电刺激参数同TEAS组,仅予以固定而不行电刺激。麻醉诱导后至手术结束前40min以0.02ml/kg/h~0.04ml/kg/h的速度维持泵注生理盐水。
|
Description for medicine or protocol of treatment in detail:
|
All patients did not use preoperative drugs. After entering the room, ECG, BP, NBP and SpO2 were routinely monitored.
1. TEAS (T) group: use Huatuo SDZ-II electronic acupuncture instrument to stimulate bilateral Zusanli, Sanyinjiao and Neiguan points 30 min before anesthesia induction to the end of the operation, with a density wave of 2/100HZ Type, current intensity 6-15mA (subject to the patient's maximum tolerance). After induction of anesthesia to 40 minutes before the end of the operation, the normal saline pump was maintained at a rate of 0.02-0.04ml/kg/h.
2.Dexmedetomidine (D) group: stick electrodes at the same acupoint 30 min before induction of anesthesia. The electrical stimulation parameters are the same as those in the TEAS group, and only fixation is performed without electrical stimulation. After induction of anesthesia to 40 minutes before the end of the operation, dexmedetomidine was injected by the pump at a rate of 0.2μg/kg/h-0.4μg/kg/h.
3. TEAS combined with dexmedetomidine (TD) group: use Huatuo SDZ-II electronic acupuncture instrument to stimulate bilateral Zusanli, Sanyinjiao and Neiguan points 30 min before anesthesia induction to the end of the operation, 2/100HZ Sparse and dense wave type, current intensity 6-15mA (subject to the patient's maximum tolerance). After induction of anesthesia to 40 minutes before the end of the operation, the dexmedetomidine pump was maintained at a rate of 0.2-0.4 μg/kg/h.
4. Blank control (C) group: electrodes were attached to the same acupoint 30 min before induction of anesthesia. The electrical stimulation parameters were the same as those in the TEAS group, and only fixed without electrical stimulation. After induction of anesthesia to 40 minutes before the end of the operation, the pump was injected with normal saline at a rate of 0.02ml/kg/h-0.04ml/kg/h.
|
纳入标准:
|
1.择期行腹腔镜妇科手术的患者;
2.年龄:18~60岁;
3.美国麻醉医师协会分级(ASA)I 级~III 级,BMI 18.5 kg/m2^~28kg/m^2。
|
Inclusion criteria
|
1. Patients undergoing elective laparoscopic gynecological surgery;
2. Age: 18-60 years;
3. American Association of Anesthesiologists (ASA) grade I-III, BMI: 18.5 kg/m^2-28kg/m^2.
|
排除标准:
|
1.匹兹堡睡眠质量指数量表评分>7分。
2.睡眠呼吸暂停,或中度以上的鼾症。
3.术前有窦性心动过缓(心率低于50次/分)或窦房结病变,二度或三度房室传导阻滞,装有起搏器者。
4.长期服用抗惊厥药、抗抑郁药或其他精神药物。
5.对本研究药物或者器材高敏或者过敏者。
6.严重的心脏、肝脏或肾脏疾病。
7.近3个月内参与过其他临床实验。
8.有听觉、语言交流障碍,不能与医师有效沟通。
9.妊娠或者哺乳的患者。
10.需要清扫淋巴结者。
11.术前存在发热或者感染的患者。
|
Exclusion criteria:
|
1. Pittsburgh sleep quality index score>7 points.
2. Sleep apnea, or moderate or more snoring.
3. Preoperative sinus bradycardia (heart rate less than 50 beats/min) or sinus node disease, second-degree or third-degree atrioventricular block, and pacemaker.
4. Long-term use of anticonvulsants, antidepressants or other psychotropic drugs.
5. Those who are highly sensitive or allergic to the drugs or equipment in this study.
6. Severe heart, liver or kidney disease.
7. Participated in other clinical trials in the past 3 months.
8. Have hearing and language communication barriers, unable to communicate effectively with doctors.
9. Patients who are pregnant or breastfeeding.
10. Those who need to clean the lymph nodes.
11. Patients with fever or infection before surgery.
|
研究实施时间:
Study execute time:
|
从From
2021-08-01
至To
2021-12-31
|
征募观察对象时间:
Recruiting time:
|
从From
2021-08-01
至To
2021-12-31
|