P-REMI trial (P-REMI trial)

Recruiting

• Conditions: Japanese pediatric surgical patients undergoing general anesthesia

• Registration Number: jRCT2031230657

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-27
• Study Start: 2024-07-18
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1, A modified gestational age of>=45 weeks and <18 years old at the time of obtaining informed consent from a surrogate 2. Patients whose trachea are intubated, and who are artificially ventilated 3. Patients scheduled to be hospitalized for at least 3 days from the day before surgery to the day after surgery 4. American Society of Anesthesiologists physical status I-III 5. Patients who have been fully informed about the clinical trial, and a legal guardian (a surrogate) of the patients provide informed consent. Patients who provide informed assent, if the patient is a junior high school student or older. If the patient is under junior high school age, written assent is obtained whenever possible.

Exclusion Criteria

1. Pregnant, lactating girl, potential pregnant, or patients who cannot consent to contracept during the study period (from the time of obtaining consent to the end of all prescribed observations). For female patients of childbearing potential, a negative pregnancy urine test must be performed from the date of obtaining consent to prior to administration of the study drug
2. Patients scheduled to receive regional anesthesia (spinal anesthesia, epidural anesthesia, or peripheral nerve block) from the time of admission to the operating room until completion of tracheal intubation (excluding the use topical local anesthetic such as Emla cream to secure intravenous line for fluid infusion or blood sampling, and test dose of local anesthetic (<=3 mL) for epidural catheter placement
3. Patients scheduled to undergo neurosurgery (excluding spine and spinal cord surgery), hepatectomy, liver transplantation, or cardiac surgery (excluding catheter intervention)
4. Emergency surgery patient
5. Patients with a scheduled surgery time less than 1 hour
6. Patients with hypertension or hypotension requiring medical treatment
7. Obese (>=30% overweight) or emaciation (>20% underweight) classified using Weight-for-Height Charts
8. Patients who require respiratory management with tracheal intubation postoperatively, and patients expected to have delayed extubation
9. Patients who have received remimazolam within 1 month
10. Patients who are taking benzodiazepines regularly or have a history of tolerance to benzodiazepines
11. Patients with a history of hypersensitivity to benzodiazepines, remifentanil hydrochloride, fentanyl citrate, rocuronium bromide, sugammadex sodium, or flumazenil
12. Patients with a history of hypersensitivity to lactose and dextran
13. Patients with acute angle-closure glaucoma
14. Patients with myasthenia gravis or myasthenic syndrome
15. Patients in shock or coma
16. Patients with rate-responsive cardiac pacemakers
17. Patients whose electroencephalogram monitoring may be unavailable due to organic brain damage
18. Patients who are expected to excessive bleeding (e.g., >15% of circulating blood volume) during surgery
19. Patients with a history of severe allergy
20. Patients with drug dependence or with a history of drug dependence
21. Patients who receive another investigational drug within 120 days before the start of CNS7056 infusion
22. Patients who have been diagnosed with developmental delay or have communication difficulty excluding neonates, infants, toddlers, and preschoolers
23. Patients whom the investigator or subinvestigator determines to be inappropriate for inclusion in the clinical trial

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
Percentage of patients who achieved loss of consciousness after the administration of CNS7056 alone		[Anesthesia induction] Percentage of patients who achieved loss of consciousness after the administration of CNS7056 alone
Percentage of anesthetic efficacy that CNS7056 provides		[Anesthesia maintenance] Percentage of anesthetic efficacy that CNS7056 provides (1) no awareness and amnesia during general anesthesia, (2) no rescue administration of anesthetic during maintenance of anesthesia, and (3) intentional movement during anesthesia

Secondary Outcome Measures

Name	Time	Method
Physical examination		blood pressure, heart rate, respiratory rate, body temperature, saturation of peripheral oxygen
Electrocardiogram		12-lead ECG at rest, 3- or 5- lead ECG
Plasma concentrations of CNS7056 and CNS7054		CNS7054 is a metabolite of CNS7056