AzTrials
AzTrials

EsketamineEarly Phase 1NCT05943028

Effect of Subanesthetic Dose Esketamine on Propofol-refentanil Closed-loop Targeted Controlled Infusion

A Early Phase 1 study testing Subanesthetic dose of esketamine in people with Esketamine, run by bo xu.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The propofol-refentanil program-controlled closed-loop target-controlled infusion system based on NI guidance has been clinically verified. In the case of clinical use of esketamine, the separation anesthesia properties do not affect the accuracy and safety of closed-loop system guidance. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Esketamine
What is being tested?
Subanesthetic dose of esketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
1 Jul 2023to 1 Oct 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

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

  • 1. Patients undergoing laparoscopic general anesthesia surgery with anesthesia duration > 60min, 2.18~55 years old, 3.BMI≥18.5kg/m2, 4. ASA Class I~II

Who cannot join

  • Exclude patients with any of the following criteria:
  • Contraindications to esketamine, propofol or refentanil;
  • Allergic reactions to egg/soy products; Hypersensitivity to fentanyl analogues;
  • Known/suspected neurological diseases, tumors, strokes, neurodegenerative diseases, severe head injuries, seizures, previous EEG abnormalities, cognitive deficits, acquired scalp/skull abnormalities, psychiatric diseases, severe depression, post-traumatic stress disorder, psychosis;
  • Taking psychotropic drugs within the past 7 days,
  • History of substance abuse/abuse or pregnancy in the past 30 days;
  • Currently involved in any other research involving drugs or devices.

Trial locations and contacts

No sites are listed yet.

Bo Xu, professor contact

+8613802738125

xubo333@hotmail.com

About this study

Official title: Chief Physician of the Department of Anesthesiology of the Southern Theater General Hospital

The propofol-refentanil program-controlled closed-loop target-controlled infusion system based on NI guidance has been clinically verified. In the case of clinical use of esketamine, the separation anesthesia properties do not affect the accuracy and safety of closed-loop system guidance. However, whether the specific degree of impact can be quantified, and based on quantitative indicators, this model can be better applied to a wider range of clinical actual conditions and different drug administration backgrounds.

Read the detailed description

The first phase is data collection on the effect of subanesthetic doses of esketamine on NI EEG in closed-loop target-controlled infusion systems for general anesthesia. According to the observation of pre-experiments and the latest literature at home and abroad, foreign studies have confirmed that esketamine does not affect the overall stability of the closed-loop system, and we verified the reliability of this conclusion through pre-experiments. In order to clarify the degree of influence of subanesthetic dose of esketamine on EEG, it is necessary to include a certain amount of esketamine applied to the anesthesia sample of closed-loop target controlled infusion system, through the main observation indicators: the change of EEG NI value after the administration of subanesthetic dose of esketamine during the anesthesia maintenance period, the change of EEG power spectrum, and the quantitative ratio change trend of brain waves (α, β, θ, δ waves). The difference in EEG NI value, power spectrum and dynamic transformation of brain wave increased due to the action of subanesthetic dose of esketamine was obtained, and the difference was quantified by the attribution of data to the degree of change of the actual EEG NI value. According to the preset guidance EEG NI value of the original closed-loop target-controlled infusion drug delivery system 36, the guidance preset value of the closed-loop system of 36+N in the clinical administration scenario of subanesthetic dose of esketamine was reset as the new EEG closed-loop feedback baseline.

The second phase is the validation of the effect of esketamine equivalent to the subanesthetic dose on closed-loop target-controlled infusion general anesthesia based on regulated NI(36+N) feedback.

Conditions
Esketamine
Being tested
Subanesthetic dose of esketamine
Keywords
closed-loop TCI, Esketamine, general anesthesia, NI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subanesthetic dose of esketamineDrug

    Also called Esketamine hydrochloride injection

    Both groups were given NI-guided propofol-refentanil dual-channel closed-loop target-controlled infusion under general anesthesia with a laryngeal mask/endotracheal intubation. The experimental group (EEG feedback index 36+N) and the control group (EEG feedback index 36) were intravenously injected esketamine 0.2mg∙kg-1 before anesthesia induction, followed by continuous 5μg∙kg-1∙min-1 infusion to maintain anesthesia for 30 minutes, and the maximum cumulative dose allowed was 100mg. In both groups, the infusion was stopped 30 minutes before the end of surgery.

Study groups in NCT05943028
Study groupRoleWhat they receive
Control groupExperimentalThe preset EEG value of 36 in closed-loop target-controlled infusion is the baseline value of EEG closed-loop feedback guidance (obtained by the team's previous research results)
Receives: Drug: Subanesthetic dose of esketamine
Experimental groupExperimentalDue to the action of esketamine in closed-loop target-controlled infusion, the EEG preset value of 36+N is the baseline value of the new EEG closed-loop feedback guidance (pre-experiment and literature data, N value is 6-8)
Receives: Drug: Subanesthetic dose of esketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG value

    Differences in EEG values between the two groups based on different feedback baselines

    Measured: From the beginning to the end of the surgery, an average of 4 hours

  2. Anesthesia maintains drug consumption

    Two groups of propofol and refentanil consumption

    Measured: From the beginning to the end of the surgery, an average of 4 hours

Secondary outcomes (3)

  1. heart rate

    Rate variations and differences throughout the process

    Measured: From the beginning to the end of the surgery, an average of 4 hours

  2. Blood pressure

    Changes and differences in blood pressure throughout the process

    Measured: From the beginning to the end of the surgery, an average of 4 hours

  3. pulse

    Changes and differences in pulse throughout the process

    Measured: From the beginning to the end of the surgery, an average of 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The control group chose the original preset value of 36 as the baseline value of EEG closed-loop feedback guidance (derived from the team's previous research results.The experimental group selected the preset value of 36+N as the baseline value of the new EEG closed-loop feedback guidance (the N value was 6-8 from the pre-experiment).Samples that met the inclusion criteria were randomized and randomly included in the experimental and control groups.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05943028
Sponsor's protocol ID
Effects of esketamine on EEG
Status last verified
Jul 2023
First submitted
27 Jun 2023
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data collection is recorded from anesthesia records in the original medical record and uploaded to Data Digital for sharing and management(https://www.bcg.com/publications/2022/how-to-build-a-data-and-digital-strategy)

Publications

  • Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

    PubMed 21233500

  • Napoleone G, van Heusden K, Cooke E, West N, Gorges M, Dumont GA, Ansermino JM, Merchant RN. The Effect of Low-Dose Intraoperative Ketamine on Closed-Loop-Controlled General Anesthesia: A Randomized Controlled Equivalence Trial. Anesth Analg. 2021 Nov 1;133(5):1215-1224. doi: 10.1213/ANE.0000000000005372.

    PubMed 33560659

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Subanesthetic dose of esketamine in people with Esketamine, 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bo Xu, professor (+8613802738125, xubo333@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG value (time frame: From the beginning to the end of the surgery, an average of 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05943028, which also lists 2 linked publications.

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 12 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in