Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT04577430 - Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period N/A
Completed NCT03708692 - Menstrual Cycle Phases on Recovery and Cognitive Function
Recruiting NCT03422315 - Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection N/A
Completed NCT02771067 - The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position N/A
Completed NCT05063461 - Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane N/A
Completed NCT03294226 - Comparison of AuraGain With I-gel for Pediatric Patients N/A
Not yet recruiting NCT03643029 - The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy N/A
Completed NCT01945411 - Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway N/A
Completed NCT01705743 - Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG Phase 4
Not yet recruiting NCT01678066 - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor N/A
Completed NCT00972491 - The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia N/A
Completed NCT01096212 - Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia Phase 4
Completed NCT00741507 - Unhealthy Alcohol Drinking and Anesthetic Requirement in Women N/A
Completed NCT00599066 - Intraoperative M-Entropy Measurements N/A
Completed NCT00532402 - Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas N/A
Completed NCT00468494 - Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia? N/A
Recruiting NCT00492453 - Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy N/A
Recruiting NCT03745079 - Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn
Completed NCT04094376 - Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia N/A
Enrolling by invitation NCT03672734 - Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia