CompletedPhase 3ketamine

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

NCT ID

NCT02987985

Target Enrollment

50 participants

Start Date

2017-10-15

Est. Completion

2020-12-20

About This Study

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.

Conditions Studied

AnesthesiaGeneral AnesthesiaAnalgesics, OpioidPostoperative ComplicationsPathologic ProcessesPhysiologic Effects of DrugsNarcoticsAnalgesicsSleep Disordered BreathingObstructive Sleep Apnea of ChildTonsillectomyRespiratory DepressionDexmedetomidineKetamineLidocaineGabapentinPulse Oximetry

Interventions

•Acetaminophen, gabapentin
•Acetaminophen
•Ketamine , Lidocaine , Dexmedetomidine
•Fentanyl, Dexmedetomidine
•Dexamethasone , Ondansetron
•Sevoflurane
•Sevoflurane, Fentanyl

Eligibility

Age:N/A - 12 Years

Healthy Volunteers:No

View full eligibility criteria

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

Study Locations (1)

Royal University Hospital

Saskatoon, Saskatchewan, Canada