Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy

University of Saskatchewan50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Anesthesia General Anesthesia Analgesics, Opioid

Interventions

Acetaminophen, gabapentinDRUG

acetaminophen 15 mg/kg, gabapentin 10 mg/kg

AcetaminophenDRUG

acetaminophen 15 mg/kg

Ketamine , Lidocaine , DexmedetomidineDRUG

Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg

Fentanyl, DexmedetomidineDRUG

Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg

Dexamethasone , OndansetronDRUG

Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg

SevofluraneDRUG

Sevoflurane (dose titrated to effect)

Sevoflurane, FentanylDRUG

Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)

Eligibility

Sex: ALLMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Respiratory depression

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