An interventional study of Propofol and Sevoflurane in Postoperative Sleep Quality, General Anesthesia and Propofol, sponsored by Yanchao Yang. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Yanchao Yang · Not applicable, Interventional, and Treatment
Adequate sleep is necessary for physical and mental health of human being. Although surgery and anesthesia techniques have improved in resent years, postoperative sleep disturbance remains a challenging problem in surgical procedures1. Postoperative sleep fragmentation and poor sleep quality can not only result in hyperalgesia and a delay in postoperative recovery2, lack of sleep after surgery can also bring many potential adverse effects such as cognitive disorders (such as delusions, delirium), chronic pain, mood disorders, metabolic disorders, and pro-inflammatory changes3-5. Previous studies have reported that age, preoperative comorbidity and severity of surgical trauma were independent factors that associated with postoperative sleep disturbance6,7. Our prior studies have also found that patients are more likely to experience decreased sleep quality after receiving general anesthesia, which was characterized by a decrease in each sleep stage8. Propofol and sevoflurane are commonly used general anesthetics in clinical practice. The choice of anesthetic may also affect the cognitive outcome after surgery, but the results of clinical studies have always been contradictory. Some studies report that the cognitive results after inhalation are worse than those after intravenous anesthesia. And the incidence of dreaming was significantly higher in the sevoflurane anesthesia group compared to the propofol group9-11. Another study conduct among infants proved that compared with propofol-remifentanil, sevoflurane appears to be associated with less sleep disturbances in the first weeks after surgery12. Based on these conflicts, the aim of the current study was to compare the effect of propofol vs sevoflurane on early postoperative sleep quality and complications of patients receiving laparoscopic surgery after general anesthesia.
Yanchao Yang is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
ASA : GradeⅠtoⅡ Laparoscopic surgery
Exclusion Criteria:
history of sleep apnea; severe neuropsychiatric disorders; long-term use of sedatives or sleeping pills; can not implement multi-lead sleep monitoring and other sleep disorders
In the Group P, propofol 4-6 mg/kg/h and remifentanil 0.2μg/kg/min were infused by intravenous pump separately for assisted sedation and assisted analgesia.
Drug: Propofol
sevoflurane (concentration: 2%-3%, mixed with 50% air and 50% oxygen to keep the minimum alveolar concentration (MAC) at 1.0-1.1) was inhaled to maintain assisted sedation, and remifentanil 0.2 μg/kg/min was infused by intravenous pump for assisted analgesia.
Drug: Sevoflurane
Group Propofol was given propofol 4mg/kg/h intravenous pumping to assist sedation
Also known as: Intravenous Anesthetics
Group Sevoflurane was given sevoflurane inhalation maintenance (concentration of 2% to 3% and mixed with 50% oxygen and air) to assist sedation；
Also known as: Inhaled Anesthetics
postoperative sleep quality of one night before surgery
Use sleep monitor to test the sleep quality one night before surgery
Time frame: one night after the surgery
postoperative sleep quality of the first night after surgery
Use sleep monitor to test the sleep quality the first night after surgery
Time frame: the first night after surgery
postoperative sleep quality of the third night after surgery
Use sleep monitor to test the sleep quality the third night after surgery
Time frame: the third night after surgery
Postoperative pain score
Use visual analog scale (VAS) score, where 0 means no pain and 10 means severe pain,to evaluate pain scores after surgery
Time frame: 24h after surgery
postoperative adverse effect
record the adverse reactions such as respiratory depression, bradycardia, nausea, vomiting and dizziness within 24 hours after surgery
Time frame: 24 hours after surgery
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Yanchao Yang