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NCT Number: NCT04123249

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Group Propofol was given propofol 4mg/kg/h intravenous pumping to assist sedation

Other names: Intravenous Anesthetics

Sevoflurane

Drug

Group Sevoflurane was given sevoflurane inhalation maintenance (concentration of 2% to 3% and mixed with 50% oxygen and air) to assist sedation;

Other names: Inhaled Anesthetics

Primary outcomes

  1. postoperative sleep quality of one night before surgery

    Time frame: one night after the surgery

    Use sleep monitor to test the sleep quality one night before surgery

  2. postoperative sleep quality of the first night after surgery

    Time frame: the first night after surgery

    Use sleep monitor to test the sleep quality the first night after surgery

  3. postoperative sleep quality of the third night after surgery

    Time frame: the third night after surgery

    Use sleep monitor to test the sleep quality the third night after surgery

Secondary outcomes

  1. Postoperative pain score

    Time frame: 24h after surgery

    Use visual analog scale (VAS) score, where 0 means no pain and 10 means severe pain,to evaluate pain scores after surgery

  2. postoperative adverse effect

    Time frame: 24 hours after surgery

    record the adverse reactions such as respiratory depression, bradycardia, nausea, vomiting and dizziness within 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Yanchao Yang

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2019
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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