Effect of Subanesthetic Dose of Esketamine on Sleep Quality and Recovery of Gastrointestinal Function in Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery in the Early Postoperative Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Changes in the level of actigraphy
研究概览
简要总结
Patients undergoing gynecological surgery are at high risk of developing postoperative sleep disorders. Intraoperative opioid use is detrimental to the patient's postoperative recovery of gastrointestinal function. Esketamine has sedative, hypnotic, analgesic, inflammatory response suppression, and antidepressant effects. Its hypnotic mechanism may be related to its rapid blockade of NMDA receptors and hyperpolarization-activated cyclic nucleotide-gated cation channels. Also can reduce the application of perioperative opioids, which in turn promotes the recovery of gastrointestinal function in patients after surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 65 years;
- •ASA class I-III;
- •Proposed laparoscopic total hysterectomy/myomectomy;
- •Operative time ≥ 1 h;
- •Body mass index of 18-30 kg/m2.
排除标准
- •Patient refusal;
- •Known allergy to anesthetic drugs;
- •Preoperative sleep disorder (Pittsburgh Sleep Quality Index [PSQI] > 7);
- •Severe hypertension, coronary artery disease, cardiac insufficiency, pulmonary hypertension, pulmonary heart disease, increased cranial pressure, increased intraocular pressure, seizures, shift work, obstructive sleep apnea syndrome;
- •Long-term use of opioids or sedative-hypnotic drugs;
- •History of psychiatric or neurological disease;
- •Previous or planned neurosurgery.
- •(7)hearing or visual impairment that precludes a scale assessment.
研究组 & 干预措施
Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h
干预措施: esketamine (Drug)
Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h
干预措施: esketamine (Drug)
结局指标
主要结局
Changes in the level of actigraphy
时间窗: Baseline (the night before surgery), postoperative nights 1 and 2
Through the actigraphy, monitor the patient's sleep quality.
Changes in the level of Pittsburgh sleep quality index
时间窗: Baseline (the night before surgery), postoperative nights 1, 2 and 3
Assess the patient's sleep quality by asking questions on the scale on a scale of 0-21, with higher scores representing poorer sleep quality.
次要结局
- Changes in the level of Melatonin(Preoperatively, upon surgery completion, postoperative day 1)
- Changes in the level of BDNF(Preoperatively, upon surgery completion, postoperative day 1)
- Changes in the level of IL-10(Preoperatively, upon surgery completion, postoperative day 1)
- Changes in the level of IL-6(Preoperatively, upon surgery completion, postoperative day 1)
- Postoperative adverse reactions(Postoperative day 1)
- Changes in the level of Oxygen saturation(Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit)
- Changes in the level of the visual analogue scale(Postoperative days 1 and 2)
- Recovery of gastrointestinal function(Postoperative first 1 day)
- Changes in the level of Heart Rate(Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit)
- Changes in the level of Mean Arterial Pressure(Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit)
研究者
Zhuan Zhang
Clinical Professor
Yangzhou University