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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123249
• Other study ID #: general anesthetics and sleep
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dreaming
• General Anesthesia
• Postoperative Sleep Quality
• Propofol
• Sevoflurane

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