The Effects of Intravenous Anesthetics and Inhaled Anesthetics on Patients' Postoperative Sleep

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Intravenous Anesthetics vs Inhaled Anesthetics on Early Postoperative Sleep Quality and Complications of Patients After Laparoscopic Surgery Under General Anesthesia

Conditions
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Postoperative Sleep Quality, General Anesthesia, Propofol, Sevoflurane, Dreaming

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Propofol<br>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<br>* Group Propofol was given propofol 4mg/kg/h intravenous pumping to assist sedation<br>* Other names: Intravenous Anesthetics;|
| Experimental: Group Sevoflurane<br>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<br>* Group Sevoflurane was given sevoflurane inhalation maintenance (concentration of 2% to 3% and mixed with 50% oxygen and air) to assist sedation；<br>* Other names: Inhaled Anesthetics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative sleep quality of one night before surgery | Use sleep monitor to test the sleep quality one night before surgery | 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 | 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 | the third night after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24h after surgery | 
| postoperative adverse effect | record the adverse reactions such as respiratory depression, bradycardia, nausea, vomiting and dizziness within 24 hours after surgery | 24 hours after surgery |