A controlled trial of automated delivery of three intravenous anesthetics using automated delivery system for total intravenous anesthesia

JRCT ID: jRCT2052190124

Registered date:26/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients who are scheduled for surgery under total intravenous anesthesia with propofol, remifentani
• Date of first enrollment: 25/03/2020
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Manually controlled anesthesia (control group): Propofol,remifentanil and rocuronium are titrated manually by the attending anesthesiologist considering patient condition
and surgical situation as usual.
Automated anesthesia (experimental group): Propofol, remifentanil and rocuronium are delivered automatically by the automated delivery system.

Outcome(s)

• Primary Outcome: Percentage of time during which an appropriate state of anesthesia was obtained within the operation time. An appropriate state of anesthesia shall be satisfied when the following three conditions are satisfied; (1) Percentage of time that BIS is maintained within the target range (35-55) from start to end of surgery, (2) The number of incidences of hemodynamic changes (increase in pulse rate and blood pressure) observed from start to end of surgery except within 5 minutes after administration of inotrope, (3) Percentage of time that muscle relaxation is maintained within the target range (0 < TOF count <= 1) from start to end of surgery

Secondary Outcome

1. Percentage of time that BIS is maintained within the target range (35-55) from start to end of surgery
2. Percentage of time the number of incidences of hemodynamic changes (increase in pulse rate and blood pressure) observed from start to end of surgery except within 5 minutes after administration of inotrope
3. Percentage of time that muscle relaxation is maintained within the target range (0 < TOF count <= 1) from start to end of surgery
4. Percentage of time during which an appropriate state of anesthesia was obtained within the operation time. An appropriate state of anesthesia shall be satisfied when the following two conditions are satisfied; (1) Percentage of time that BIS is maintained within the target range (35-55) from start to end of surgery, (2) The number of incidences of hemodynamic changes (increase in pulse rate and blood pressure) observed from start to end of surgery except within 5 minutes after administration of inotrope
5. Percentage of time during which an appropriate state of anesthesia was obtained within the operation time. An appropriate state of anesthesia shall be satisfied when the following two conditions are satisfied; (1) Percentage of time that BIS is maintained within the target range (35-55) from start to end of surgery, (2) Percentage of time that muscle relaxation is maintained within the target range (0 < TOF count <= 1) from start to end of surgery
6. Percentage of time that BIS maintained an appropriate state of anesthesia from start to end of surgery
7. Time from the end of rocuronium administration to the recovery of TOF ratio over 0.9.
8. Time from the end of propofol administration to awake from anesthesia

Key inclusion & exclusion criteria

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

Include criteria

1. Male and female patients over 20 years old at the time of informed consent
2. Patients with ASA physical status of 1, 2, and 3 who are scheduled for surgery under general anesthesia
3. Patients who understand the contents of this study and are willing to provide written informed consent for participation in this study

Exclude criteria

1. Patients with a history of hypersensitive to propofol, remifentanil, rocuronium or sugammadex.
2. Patients who cannot connected BIS Sensor for placement on the forehead.
3. Patients who cannot received rocuronium after first single dose.
4. Patients who cannot measured non-invasive sphygmomanometer.
5. Patients undergoing surgery with hypothermia.
6. Patients undergoing cardiovascular surgery.
7. Patients undergoing surgery with nerve block.
8. Patients who are pregnant or lactating.
9. Patients who participated in another trial within 12 weeks before obtaining informed consent.
10. Patients who are determined not to be eligible for participation in this study by the research director.

Related Information

• Primary Sponsor: Shigemi Kenji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)