Combined propofol and sevoflurane anesthesia

JRCT ID: jRCT1011240054

Registered date:27/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases requiring surgery under general anesthesia
• Date of first enrollment: 02/12/2024
• Target sample size: 444
• Study type: Interventional

Intervention(s)

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 (target controlled infusion) of propofol. Effect-site concentration of propofolof is started at 3 micg/mL and adjusted.
2. Sevoflurane group: Anesthesia is induced by intravenous injection of 1-2.5 mg of propofol. Anesthesia is maintained with sevoflurane at 2/3 MAC (minimum alveolar concentration) or higher.
3. Propofol and sevoflurane group: Anesthesia is induced by intravenous injection of 1-2.5 mg of propofol. Anesthesia is maintained with 1/3 MAC of sevoflurane and propofol. Propofol is started at 3 mg/kg/h and adjusted Immediately after induction of anesthesia.

Outcome(s)

Primary Outcome

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.

Secondary Outcome

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.

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 continuous opioid infusion
7. Operation time (above or below the median)

Postoperative pain (NRS: Numerical Rating Scale)
Postoperative course and complications until discharge
Frequency of anesthesia coordination and nursing care
Healthcare costs

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 20age old over
2. The scheduled operation time is more than 2 hours
3. General anesthesia with tracheal intubation

Exclude 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

Related Information

• Primary Sponsor: Yusuke Yoshikawa