Feasibility of Closed-loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine

Phase 4

Not yet recruiting

• Conditions: Closed-Loop; General Anesthesia With Propofol
• Interventions: Drug: Esketamine at low dose; Drug: an equivalent dose of saline; Device: new BIS baseline; Device: original BIS baseline

• Registration Number: NCT06729892
• Lead Sponsor: bo xu

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.

Study Timeline

• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-07
• Study First Posted: 2024-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Study Start: 2025-01-20
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjusted-group	Esketamine at low dose	After administering esketamine at low dose , this group adjusted drug dosage under closed-loop control based on the new BIS baseline(50＋N).
Adjusted-group	new BIS baseline	After administering esketamine at low dose , this group adjusted drug dosage under closed-loop control based on the new BIS baseline(50＋N).
Non-adjusted group	Esketamine at low dose	After administering esketamine at low dose, this group adjusted drug dosage under closed-loop control based on the original BIS baseline(50).
Non-adjusted group	original BIS baseline	After administering esketamine at low dose, this group adjusted drug dosage under closed-loop control based on the original BIS baseline(50).
control group	an equivalent dose of saline	This group adjusted drug dosage under closed-loop control based on the original BIS baseline(50) with an equivalent volume of saline.
control group	original BIS baseline	This group adjusted drug dosage under closed-loop control based on the original BIS baseline(50) with an equivalent volume of saline.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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
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.
extra analgesic drugs usage	From transfer into and out PACU