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

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

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.

Study Overview

• Status: Completed
• Conditions: Sevoflurane; General Anesthesia; Propofol; Postoperative Sleep Quality; Dreaming
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Propofol; 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; Group Propofol was given propofol 4mg/kg/h intravenous pumping to assist sedation; Other Names: Intravenous Anesthetics
Experimental: Group Sevoflurane; 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 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yanchao Yang

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 3, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Sevoflurane; Anesthetics, Intravenous
• Other Study ID Numbers: general anesthetics and sleep

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No