Diseases requiring surgery under general anesthesia
Conditions
Interventions
Subjects are randomly assigned to a propofol alone group, a sevoflurane alone group, or a combination of propofol and sevoflurane group.
1. Propofol group: Anesthesia is induced and maintained by TCI
Sponsors
Yusuke Yoshikawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 20age old over 2. The scheduled operation time is more than 2 hours 3. General anesthesia with tracheal intubation
Exclusion criteria
Exclusion criteria: 1. Emergent case 2. Cardiovascular surgery using cardiopulmonary bypass or coronary artery bypass surgery 3. Transcatheter aortic valve implantation 4. One lung ventilation 5. Intracranial surgery 6. Surgery with restrictions on the use of sevoflurane or propofol 7. NYHA (New York Heart Association) classification 3 or 4 8. Dialysis or eGFR (estimated glomerular filtration rate) <30 mL/min/1.73m2 9. Child-Pugh classification B or C 10. BMI (Body Mass Index) of 35 kg/m2 or higher 11. Patients who had tracheal intubation or tracheotomy before surgery 12. Patients who are unconscious or have difficulty communicating before surgery 13. Patients who used sedatives or opioids within 6 hours before anesthesia 14. Patients receiving continuous intravenous infusion of sedatives after surgery 15. Patients who end general anesthesia after surgery while still intubated 16. Patients who cannot provide written consent 17. Patients who are allergic to the medication used 18. Patients who are deemed inappropriate by the operating room manager
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who rated the quality of anesthesia as good *The definition of Good will be stated only in the study protocol and will not be disclosed. This is to prevent medical professionals from intentionally conducting perioperative management or evaluations that do or do not meet the criteria for Good. *On October 1, 2025, following the completion of the assessment of all study outcomes, we publicly released the definition of Good. Good is defined as meeting all of the following criteria: (1) No intraoperative awareness (2) Extubation within 15 minutes after discontinuation of sevoflurane and/or propofol, without requiring airway management or respiratory support including reintubation, jaw thrust and mask ventilation (3) No PONV within 24 hours after surgery (4) No emergence agitation (defined as a Riker Sedation Agitation Scale score of 3, 4 or 5) (5) No severe coughing during emergence (defined as a four-points cough score of 1, 2 or 3) (6) No postoperative shivering within 24 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who rated the quality of anesthesia as excellent *The definition of Excellent will be stated only in the study protocol and will not be disclosed. This is to prevent medical professionals from intentionally conducting perioperative management or evaluations that do or do not meet the criteria for Excellent. *On October 1, 2025, following the completion of the assessment of all study outcomes, we publicly released the definition of Excellent. Excellent is defined as meeting all of the following criteria: (1) No intraoperative awareness (2) Extubation within 10 minutes after discontinuation of sevoflurane and/or propofol, without requiring airway management or respiratory support including reintubation, jaw thrust and mask ventilation (3) No PONV within 24 hours after surgery (4) No emergence agitation (defined as a Riker Sedation-Agitation Scale score of 3 or 4) (5) No severe coughing during emergence (defined as a four-points cough score of 1 or 2) (6) No postoperative shivering within 24 hours after surgery (7) No unintended body movement or spontaneous breathing during surgery (8) No postoperative delirium within 24 hours after surgery. Delirium was defined as an Intensive Care Delirium Screening Checklist (ICDSC) score of 4 or higher, or a Neelon and Champagne Confusion Scale (NEECHAM) score of 24 or lower. Details of each element included in Good and Excellent. Number and percentage of adverse events 1. Awakened during surgery 2. Delayed awakening (more than 30 minutes from the end of administration of sevoflurane or propofol to extubation) 3. Required airway management or respiratory support immediately after extubation (reintubation, chin thrust, mask ventilation) Subgroup analysis 1. Age (over or under 50 years old) 2. Sex 3. Smoking history 4. History of PONV or motion sickness 5. Surgery type (gynecologic surgery, cholecystectomy, laparoscopic surgery, and others) 6. Epidural anesthesia or peripheral nerve block 6. Postoperative co | — |
Contacts
Public ContactKunigo Tatsuya
Sapporo Medical University, School of Medicine
Outcome results
None listed