Closed-Loop, General Anesthesia With Propofol
Conditions
Keywords
eskemine, close-loop TCI, EEG, depth of anesthesia
Brief summary
The propofol-remifentanil closed-loop TCI system based on EEG guidance has been clinically verified, which enables more precise anesthetic dosing. As an adjunct to anesthesia, esketamine has been shown to stabilize hemodynamics, reduce opioid use, and reduce postoperative nausea and vomiting. However, due to its specific electroencephalographic excitatory effect, esketmine's clinical use in close-loop system has been limited. The aim of this experiment was to determine the specific impact of esketamine on EEG and thus obtain a new EEG baseline for close-loop system, which can broaden the application of close-loop TCI system in combination with other drugs.
Detailed description
The trial is devided into two phases. In the first phase, we statistically analyzed and calculated the changes of BIS by collecting a sample size of EEG changes after administering low dose of esketamine. We used 0.2 mg/kg as a loading dose and followed by a rate of 5ug/kg/min as esketamine administration and observe the changes in BIS each for 30 minutes. In the second phase, we obtain the BIS quantification value N with the addition of a small dose of esketamine in the first phase and thus obtain a new EEG baseline 50+N. By comparing this EEG-adjusted group with the control group, which run the close-loop system based on original BIS baseline without esketamine, whether the closed-loop system can be better applied based on the new BIS baseline under low dose of esketamine.
Interventions
Esketamine at low dose was administered(0.2mg· kg-1, 5 ug· kg-1 continuous infusion) and drug dosage was adjusted(propofol and remifentanil) based on the new BIS baseline ( calculated from the pilot study).
DEVICEnew BIS baseline
Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose.
DRUGan equivalent dose of saline
An equivalent dose of saline was given and closed-loop control stared.
DEVICEoriginal BIS baseline
Drug dosage was adjused under close-loop control based on original BIS baseline.
Sponsors
bo xu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* BMI 18\ 27kg· m-2; * American Society of Anesthesiologists (ASA)physical status I\ II; * Undergoing elective laparoscopic surgery.
Exclusion criteria
* Known or suspected neurological diseases, tumors, stroke, degenerative neurological diseases, epileptic seizures, serious head injuries, cognitive disorders, post-traumatic stress disorder, mental illnesses, severe depression, psychosis, etc.; * Contraindications to ketamine, propofol or remifentanil; * Use of psychotropic drugs within the past 7 days; * History of drug abuse or drug addiction within the past 30 days or during pregnancy; * Current participation in any other studies involving other drugs or devices.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BIS, % of time within ± 10 units of the BIS setpoint during closed-loop control | time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min | % of time within ± 10 units of the BIS setpoint is the most commonly used metric to evaluate performance of closed-loop control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic changes during closed-loop control | time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min | — |
| Postoperative recovery assessment | time to BIS>80, time to regain spontaneous breathing, time to answering questions and time to extubate | — |
| VAS | time from PACU administration to transfer out from PACU. | visual analgesic score, one of a most commonly used critieria of pain intensity. VAS ranges from 0\ 10, 0\ 3 indicates slight or no pain; 4\ 6 indicates Moderate pain; 7\ 10 indicates severe pain. |
| drug consumption | time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min | drug consumption of propofol and remifentanil |
| occurrance of nausea and vomiting, shivering | From transfer into and out PACU | — |
| intraoperative awareness assessment, 15-item quality of recovery (QoR-15) | From postoperative day 1st to day 7th. | Intraoperative awareness is assessed by modified Brice questionnaire; This questionnaire consists of 5 questions. Level of Intraoperative awareness ranges from 0\ 5. The QoR-15 questionnaire is composed of 15 questions, including physical comfort (5 items), emotional state (4 items), physical independence (2 items), psychological support (2 items), and pain(2 items). The higher of the QoR-15 scores, the better of the quality of recovery after surgery (range is 0 to 150 points). |
| extra analgesic drugs usage | From transfer into and out PACU | — |
Contacts
Primary Contactxiaoshan Li, postgraduate
Backup Contactbo Xu, Doctor, chief director.
Outcome results
None listed