Remimazolam and flumazenil for Rapid Sequence Awakeness method in pediatric anesthesia

JRCT ID: jRCTs021240059

Registered date:06/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases for which scheduled surgery is performed under general anesthesia
• Date of first enrollment: 06/02/2025
• Target sample size: 108
• Study type: Interventional

Intervention(s)

Awake group: Maintain anesthesia with sevoflurane, and extubate after confirming the patient's awakening.
RSA group: Switch from sevoflurane to remimazolam as maintenance drug before the end of surgery, and administer flumazenil and extubate the patient after confirming spontaneous respiration

Outcome(s)

• Primary Outcome: Incidence of EA/ED up to 15 minutes after awakening and extubating

Secondary Outcome

PAEDs score on admission to the PICU and at each time point (*) after admission to the PICU
Percentage of EAs/EDs on admission to the PICU and at each time point (*) after admission to the PICU
Percentage of PRAEs in the operating room
Percentage of PRAEs occurring up to 2 hours after PICU admission
Percentage of cases requiring airway/respiratory intervention within 2 hours of PICU admission
Percentage of resuscitations within 2 hours of PICU admission
Time from end of surgical procedure to patient leaving the operating room
FLACCs score after extubation
FLACCs score on admission to PICU and at each assessment time point (*)
Subjective assessment by anesthesiologist of quality of emergence and extubation from general anesthesia.
*Evaluation time points are defined as at the time of admission to the PICU + 10 minutes and 30 minutes +/- 10 minutes, 60 minutes +/- 10 minutes, and 120 minutes +/- 10 minutes after admission to the PICU.

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: <= 6age 12month old
• Gender: Both

Include criteria

Patients scheduled for surgery under general anesthesia who meet the following criteria.
1) Patients 1-6 years of age at the time of consent.
2) Patients with an American Society of Anesthesiologists physical status (ASA-PS) of 1-2 at the preoperative visit.
3) Patients scheduled to have their airway secured by oral tracheal intubation.
4) Patients scheduled for extubation in the operating room.
5) Patients who have been fully informed about the study and have provided written informed consent from a surrogate.

Exclude criteria

1) Patients scheduled to undergo craniotomy
2) Patients whose scheduled operation time is less than 20 minutes but longer than 4 hours
3) Patients who are expected to bleed heavily (more than 15% of circulating blood volume) during surgery
4) Patients who are expected to have difficulty with mask ventilation, intubation, but extubation
5) At risk of vomiting or aspiration during the perioperative period
6) Patients with a history of severe allergy to benzodiazepines, flumazenil citrate, remifentanil hydrochloride, fentanyl citrate, rocuronium bromide, or sugammadex sodium
7) Patients who have been taking benzodiazepines regularly before surgery or have a history of tolerance to benzodiazepines
8) Patients with a history of epilepsy
9) Patients with a history of glaucoma
10) Other patients deemed inappropriate by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Yakushiji Tatsumi