Diseases for which scheduled surgery is performed under general anesthesia
Conditions
Interventions
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 surger
Sponsors
Yakushiji Tatsumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of EA/ED up to 15 minutes after awakening and extubating | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactTatsumi Yakushji
Fukushima Medical University Hospital
Outcome results
None listed