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

JRCT ID: jRCTs032180067

Registered date:28/12/2018

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: 25/03/2019
• Target sample size: 60
• Countries of recruitment: Japan only,Japan
• 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 robotic anesthesia system.

Outcome(s)

• Primary Outcome: Percentage of time during which an appropriate state of anesthesia was obtained within the operation time (before and after data cleaning). 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% < T1 <= 10%) 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 (before and after data cleaning)
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 (before and after data cleaning)
3. Percentage of time that muscle relaxation is maintained within the target range (0% < T1 <= 10%) from start to end of surgery (before and after data cleaning)
4. Percentage of time that propofol is overdosed (BIS < 35) from start to end of surgery (before and after data cleaning)
5. Percentage of time that propofol is underdosed (BIS > 55) from start to end of surgery (before and after data cleaning)
6. Average and median of BIS (before and after data cleaning)
7. Incidence of body movement (before and after data cleaning)
8. Average dosage of propofol per hour
9. Average dosage of remifentanil per hour
10. Average dosage of rocuronium per hour
11. Time from the end of rocuronium administration to the recovery of %T1 over 100% or of TOF ratio over 0.9
12. Anesthesia-related adverse events that occurred within 48 hours after surgery (incidence of PONV, shivering, delirium and percentage of patients who received additional analgesic agent)

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 are pregnant or lactating.
3.Patients who are determined not to be eligible for participation in this study by the research director.

Related Information

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