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

NCT ID: NCT06729892

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-05-30

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.

Conditions

General Anesthesia With Propofol; Closed-Loop

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Adjusted-group

After administering esketamine at low dose , this group adjusted drug dosage under closed-loop control based on the new BIS baseline(50＋N).

Group Type: EXPERIMENTAL

Esketamine at low dose

Intervention Type: 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).

new BIS baseline

Intervention Type: DEVICE

Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose.

Non-adjusted group

After administering esketamine at low dose, this group adjusted drug dosage under closed-loop control based on the original BIS baseline(50).

Group Type: EXPERIMENTAL

Esketamine at low dose

Intervention Type: 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).

original BIS baseline

Intervention Type: DEVICE

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

control group

This group adjusted drug dosage under closed-loop control based on the original BIS baseline(50) with an equivalent volume of saline.

Group Type: PLACEBO_COMPARATOR

an equivalent dose of saline

Intervention Type: DRUG

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

original BIS baseline

Intervention Type: DEVICE

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

Interventions

Esketamine at low dose

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).

Intervention Type: DRUG

new BIS baseline

Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose.

Intervention Type: DEVICE

an equivalent dose of saline

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

Intervention Type: DRUG

original BIS baseline

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

bo xu

OTHER

Sponsor Role: lead

Responsible Party

bo xu

Doctor; Chief director.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

BO xu, doctor, chief director

Role: STUDY_DIRECTOR

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

Central Contacts

xiaoshan Li, postgraduate

Role: CONTACT

1225564331@qq.com

86 + 17820686302

bo Xu, Doctor, chief director.

Role: CONTACT

xubo333@hotmail.com

86 + 13802738125

Other Identifiers

62076253

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

82472110

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GuangzhouGH

Identifier Type: -

Identifier Source: org_study_id