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

NCT04123249 | Completed

• 1 other identifier: general anesthetics and sleep
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Postoperative pain score

  24h after surgery

• postoperative adverse effect

  24 hours after surgery

Study Arms (2)

Group Propofol

EXPERIMENTAL

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 Sevoflurane

EXPERIMENTAL

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

Interventions

Propofol DRUG

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

Also known as: Intravenous Anesthetics

Group Propofol

Sevoflurane DRUG

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

Also known as: Inhaled Anesthetics

Group Sevoflurane

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA : GradeⅠtoⅡ Laparoscopic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Yanchao Yang: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Interventions

Propofol; Anesthetics, Intravenous; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: May 20, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 30, 2020
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

CN (1)