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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04123249
Other study ID # general anesthetics and sleep
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2020
Est. completion date November 30, 2020

Study information

Verified date January 2021
Source Shengjing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date November 30, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: ASA : Grade?to? 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

Study Design


Intervention

Drug:
Propofol
Group Propofol was given propofol 4mg/kg/h intravenous pumping to assist sedation
Sevoflurane
Group Sevoflurane was given sevoflurane inhalation maintenance (concentration of 2% to 3% and mixed with 50% oxygen and air) to assist sedation;

Locations

Country Name City State
China Shengjing Hospital Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Yanchao Yang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
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