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

NCT05943028 | Unknown Early Phase 1 DMC

• 1 other identifier: Effects of esketamine on EEG
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Esketamine

Keywords

closed-loop TCI; Esketamine; general anesthesia; NI

Outcome Measures

Primary Outcomes (2)

• EEG value

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

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

• Anesthesia maintains drug consumption

  Two groups of propofol and refentanil consumption

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

Secondary Outcomes (3)

• heart rate

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

• Blood pressure

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

• pulse

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

Study Arms (2)

Control group

EXPERIMENTAL

The 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)

Drug: Subanesthetic dose of esketamine

Experimental group

EXPERIMENTAL

Due 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)

Drug: Subanesthetic dose of esketamine

Interventions

Subanesthetic dose of esketamine DRUG

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.

Also known as: Esketamine hydrochloride injection

Control group; Experimental group

Eligibility Criteria

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

You may qualify if:

• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• bo xu: lead

Related Publications (2)

• 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.

  PMID: 21233500 BACKGROUND

• 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.

  PMID: 33560659 BACKGROUND

Study Officials

• Shengchao Li, Graduate

  The First Clinical College of Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Xu, professor

CONTACT

+8613802738125; xubo333@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants were assigned to the management and control groups, and neither group of researchers nor subjects was clear about their group. Data statistical analysts and clinical trial participants maintain independence in their work.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 12, 2023
• Study Start: July 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share