General Anesthesia With PropofolPhase 4NCT06729892
Feasibility of Closed-loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine
A Phase 4 study testing Esketamine at low dose, new BIS baseline and an equivalent dose of saline in people with General Anesthesia With Propofol and Closed-Loop, run by bo xu.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- General Anesthesia With Propofol, Closed-Loop
- What is being tested?
- Esketamine at low dose, new BIS baseline and an equivalent dose of saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 30 May 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 18~27kg· m-2;
- American Society of Anesthesiologists (ASA)physical status I~II;
- Undergoing elective laparoscopic surgery.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility of Closed-loop TCI Based on New BIS Baseline in the Presence of Low Dose of Esketamine: a Randomized Controlled Equivalence Trial.
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.
Read the 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
- Being tested
- Esketamine at low dose, new BIS baseline, an equivalent dose of saline, original BIS baseline
- Keywords
- eskemine, close-loop TCI, EEG, depth of anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine at low doseDrug
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 baselineDevice
Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose.
an equivalent dose of salineDrug
An equivalent dose of saline was given and closed-loop control stared.
original BIS baselineDevice
Drug dosage was adjused under close-loop control based on original BIS baseline.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Drug: an equivalent dose of saline; Device: original BIS baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
Secondary outcomes (7)
drug consumption
drug consumption of propofol and remifentanil
Measured: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
hemodynamic changes during closed-loop control
Measured: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
Postoperative recovery assessment
Measured: 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.
Measured: time from PACU administration to transfer out from PACU.
extra analgesic drugs usage
Measured: From transfer into and out PACU
occurrance of nausea and vomiting, shivering
Measured: 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).
Measured: From postoperative day 1st to day 7th.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start20 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthesia With PropofolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- bo xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
- Investigators
- BO xu, doctor, chief director, Study director, department of anesthesiology, southern theater general hospital of PLA, Guangzhou, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729892
- Sponsor's protocol ID
- GuangzhouGH
- Other IDs
- 62076253, 82472110
- Status last verified
- Jan 2025
- First submitted
- 7 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Closed-loop TCI Based on New BIS Baseline in the Presence of Low Dose of Esketamine: a Randomized Controlled Equivalence Trial.
- ClinicalTrials.gov ID
- NCT06729892
- Acronym / sponsor ID
- GuangzhouGH
- Conditions
- General Anesthesia With Propofol, Closed-Loop
- Keywords
- eskemine, close-loop TCI, EEG, depth of anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- bo xuUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adjusted-group | Experimental | Drug: Esketamine at low dose, Device: new BIS baselineAfter 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 | Experimental | Drug: Esketamine at low dose, Device: original BIS baselineAfter administering esketamine at low dose, this group adjusted drug dosage under closed-loop control based on the original BIS baseline(50). |
| control group | Placebo comparator | Drug: an equivalent dose of saline, Device: original BIS baselineThis group adjusted drug dosage under closed-loop control based on the original BIS baseline(50) with an equivalent volume of saline. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18~27kg· m-2;
- American Society of Anesthesiologists (ASA)physical status I~II;
- Undergoing elective laparoscopic surgery.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esketamine at low doseEsketamine 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). | Drug | Adjusted-group, Non-adjusted group |
| new BIS baselineClose-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose. | Device | Adjusted-group |
| an equivalent dose of salineAn equivalent dose of saline was given and closed-loop control stared. | Drug | control group |
| original BIS baselineDrug dosage was adjused under close-loop control based on original BIS baseline. | Device | Non-adjusted group, control group |
Primary outcome
BIS, % of time within ± 10 units of the BIS setpoint during closed-loop control
Time frame: 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.
7 secondary outcomes
drug consumption
Time frame: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
hemodynamic changes during closed-loop control
Time frame: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
Postoperative recovery assessment
Time frame: time to BIS>80, time to regain spontaneous breathing, time to answering questions and time to extubate
VAS
Time frame: time from PACU administration to transfer out from PACU.
extra analgesic drugs usage
Time frame: From transfer into and out PACU
occurrance of nausea and vomiting, shivering
Time frame: From transfer into and out PACU
intraoperative awareness assessment, 15-item quality of recovery (QoR-15)
Time frame: From postoperative day 1st to day 7th.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BO xu, doctor, chief director study director
department of anesthesiology, southern theater general hospital of PLA, Guangzhou, China.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine at low dose, new BIS baseline and an equivalent dose of saline in people with General Anesthesia With Propofol and Closed-Loop, run by bo xu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaoshan Li, postgraduate (86 + 17820686302, 1225564331@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIS, % of time within ± 10 units of the BIS setpoint during closed-loop control (time frame: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.