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

NCT06729892 | Not Yet Recruiting Phase 4 DMC

• 3 other identifiers: GuangzhouGH6207625382472110
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

General Anesthesia With Propofol; Closed-Loop

Keywords

eskemine; close-loop TCI; EEG; depth of anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• drug consumption

  time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min

• 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.

• extra analgesic drugs usage

  From transfer into and out PACU

Study Arms (3)

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).

Drug: Esketamine at low dose; Device: new BIS baseline

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).

Drug: Esketamine at low dose; Device: original BIS baseline

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.

Drug: an equivalent dose of saline; Device: original BIS baseline

Interventions

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).

Adjusted-group; Non-adjusted group

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.

Adjusted-group

an equivalent dose of saline DRUG

An equivalent dose of saline was given and closed-loop control stared.

control group

original BIS baseline DEVICE

Drug dosage was adjused under close-loop control based on original BIS baseline.

Non-adjusted group; control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18\~27kg· m-2;
• American Society of Anesthesiologists (ASA)physical status I\~II;
• Undergoing elective laparoscopic surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• bo xu: lead

Study Officials

• BO xu, doctor, chief director

  department of anesthesiology, southern theater general hospital of PLA, Guangzhou, China.

  STUDY DIRECTOR

Central Study Contacts

xiaoshan Li, postgraduate

CONTACT

86 + 17820686302; 1225564331@qq.com

bo Xu, Doctor, chief director.

CONTACT

86 + 13802738125; xubo333@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor; Chief director.

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 12, 2024
• Study Start: January 20, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share