Emergence Delirium, Remimazolam, Tonsillectomy
Conditions
Keywords
Remimazolam
Brief summary
The aim of this study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, American Society of Anesthesiologists (ASA) physical status I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously. The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be postoperative pain level, length of stay in the recovery room, presence of unwanted events in the recovery room, presence of postoperative mood changes, as well as parental satisfaction.
Detailed description
The aim of this study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, ASA classification I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously. The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be postoperative pain level, length of stay in the recovery room, presence of unwanted events in the recovery room, presence of postoperative mood changes, as well as parental satisfaction.
Interventions
Remimazolam 0.1 mg/kg intravenous injection
DRUGNaCl (0,9%)
NaCl 0.9% 0.04 mL/kg
Sponsors
University Hospital of Split
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status I * Children undergoing scheduled tonsillectomy/adenoidectomy or combined procedure
Exclusion criteria
* American Society of Anesthesiologists (ASA) physical status \> 1 * Known hypersensitivity to remimazolam or other benzodiazepines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAED (pediatric anesthesia emergence delirium scale) | Perioperative - immediately after extubation and 3 times after that every 10 minutes | The PAED scale consists of 5 criteria that are scored using a 5-point scale. A score greater than 10 (or greater than 12) represents emergence delirium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FLACC ( Face, Legs, Activity, Cry, Consolability scale for assessing pain) | Perioperative - immediately after extubation and 3 times after that every 10 minutes | The scale is scored from 0 to 10, where 0 represents no pain and higher scores indicate greater pain. |
Countries
Croatia
Contacts
PRINCIPAL_INVESTIGATORFilip Peris
University Hospital of Split
Outcome results
None listed