Analgesics, Analgesics, Opioid, Anesthesia, Dexmedetomidine, Gabapentin, General Anesthesia, Ketamine, Lidocaine, Narcotics, Obstructive Sleep Apnea of Child, Pathologic Processes, Physiologic Effects of Drugs, Postoperative Complications, Pulse Oximetry, Respiratory Depression, Sleep Disordered Breathing, Tonsillectomy
Conditions
Keywords
Opioid-sparing, Opioid-free
Brief summary
The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative respiratory depression in children with sleep-disordered breathing.
Detailed description
The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques.
Interventions
acetaminophen 15 mg/kg, gabapentin 10 mg/kg
DRUGAcetaminophen
acetaminophen 15 mg/kg
DRUGKetamine , Lidocaine , Dexmedetomidine
Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg
DRUGFentanyl, Dexmedetomidine
Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg
DRUGDexamethasone , Ondansetron
Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg
DRUGSevoflurane
Sevoflurane (dose titrated to effect)
DRUGSevoflurane, Fentanyl
Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 0-12 years with Sleep Disordered Breathing (SDB) who are scheduled for elective Tonsillectomy/AdenoTonsillectomy (T/AT) will be recruited at Royal University Hospital, Saskatoon, Saskatchewan.
Exclusion criteria
* age \> 12; American Society of Anesthesiologists (ASA) Classification \> IV; significant cardiorespiratory, neurological, craniofacial, hepatic, renal, or genetic disorders, excluding SDB; concomitant surgical procedures other than myringotomy and tubes; and allergy to any of the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory depression | 24 hours following surgery | Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) \<90%) as measured by a Masimo Radical-7 pulse oximeter during the first postoperative night's sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantified opioid consumption | 24 hours following surgery | Quantified opioid consumption |
| Pediatric Agitation Emergence Delirium (PAED) scale | 24 hours following surgery | Pediatric Agitation Emergence Delirium (PAED) scale |
| Face Legs Activity Cry Consolability (FLACC) scale | 24 hours following surgery | Face Legs Activity Cry Consolability (FLACC) scale |
| Time until Post Anesthesia Care Unit (PACU) discharge readiness | 24 hours following surgery | Time until Post Anesthesia Care Unit (PACU) discharge readiness |
| Other adverse effects | 24 hours following surgery | Other adverse effects |
Countries
Canada
Outcome results
None listed