Examination of sedative and analgesic requirements in a robotic anesthesia system(Automated delivery of three intravenous anesthetics using robotic anesthesia system for TIVA)

JRCT ID: jRCTs052200118

Registered date:22/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with ASA physical status 1-3, scheduled for surgery under total intravenous anesthesia
• Date of first enrollment: 10/03/2021
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Propofol, remifentanil and rocuronium are delivered automatically by the robotic anesthesia system

Outcome(s)

• Primary Outcome: Percentage of time when the effects of sedation, analgesia and muscle relaxation were all properly maintained during surgery

Secondary Outcome

1.Percentage of time sedation was adequately maintained during surgery
2.Percentage of time the analgesic effect was adequately maintained during surgery
3.Percentage of time that the effect of muscle relaxation was adequately maintained during surgery time
4.Percentage of time when both sedative and analgesic effects were adequately maintained during surgery
5.Percentage of time during which the effects of sedation and muscle relaxation were adequately maintained during 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 propofol administration to awakening of anesthesia
8.Time from sugammadex administration to recovery of TOF ratio to 0.9 or more
9.Effect site concentaration and plasma of concentaration of Rb at at the time when TOF level is restored to 1 after the initial administration of Rb and when it is stable
10. Sugammadex dosage
11.Amount required for the second dose after sugammadex 2 mg/kg
12.Whether recurricularization occurs after resuming spontaneous breathing ( Observation within 24 hours after surgery)
13.EsMIC value, a,b,c value for each age

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.Pregnant patients or patients having a possibility of pregnancy. Patients who are breast feeding or attempting to become pregnant.
8.Patients who participated in another trial within 12 weeks before obtaining informed consent.
9.Patients who are determined not to be eligible for participation in this study by the research director

Related Information

• Primary Sponsor: Matsuki Yuka