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| ID | Type | Description | Link |
|---|---|---|---|
| 62076253 | Other Grant/Funding Number | Bo Xu | |
| 82472110 | Other Grant/Funding Number | Bo Xu |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjusted-group | Experimental | After administering esketamine at low dose , this group adjusted drug dosage under closed-loop control based on the new BIS baseline(50＋N). |
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| Non-adjusted group | Experimental | After administering esketamine at low dose, this group adjusted drug dosage under closed-loop control based on the original BIS baseline(50). |
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| control group | Placebo Comparator | This group adjusted drug dosage under closed-loop control based on the original BIS baseline(50) with an equivalent volume of saline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine at low dose | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| BIS, % of time within ± 10 units of the BIS setpoint during closed-loop control | % of time within ± 10 units of the BIS setpoint is the most commonly used metric to evaluate performance of closed-loop control. | time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min |
| Measure | Description | Time Frame |
|---|---|---|
| drug consumption | drug consumption of propofol and remifentanil | time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min |
| hemodynamic changes during closed-loop control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaoshan Li, postgraduate | Contact | 86 + 17820686302 | 1225564331@qq.com | |
| bo Xu, Doctor, chief director. | Contact | 86 + 13802738125 | xubo333@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| BO xu, doctor, chief director | department of anesthesiology, southern theater general hospital of PLA, Guangzhou, China. | Study Director |
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| new BIS baseline | Device | Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose. |
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| an equivalent dose of saline | Drug | An equivalent dose of saline was given and closed-loop control stared. |
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| original BIS baseline | Device | Drug dosage was adjused under close-loop control based on original BIS baseline. |
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| 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 | 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. | time from PACU administration to transfer out from PACU. |
| extra analgesic drugs usage | From transfer into and out PACU |
| occurrance of nausea and vomiting, shivering | From transfer into and out PACU |
| intraoperative awareness assessment, 15-item quality of recovery (QoR-15) | 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). | From postoperative day 1st to day 7th. |