Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study
Overview
- Phase
- Phase 3
- Intervention
- Acetaminophen, gabapentin
- Conditions
- Pathologic Processes
- Sponsor
- University of Saskatchewan
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Respiratory depression
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Jonathan Gamble
Principle Investigator
University of Saskatchewan
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
Arms & Interventions
Opioid-free anesthesia
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis
Intervention: Acetaminophen, gabapentin
Opioid-free anesthesia
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis
Intervention: Ketamine , Lidocaine , Dexmedetomidine
Opioid-free anesthesia
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis
Intervention: Dexamethasone , Ondansetron
Opioid-free anesthesia
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis
Intervention: Sevoflurane
Opioid-sparing anesthesia
Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
Intervention: Acetaminophen
Opioid-sparing anesthesia
Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
Intervention: Fentanyl, Dexmedetomidine
Opioid-sparing anesthesia
Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
Intervention: Dexamethasone , Ondansetron
Opioid-sparing anesthesia
Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
Intervention: Sevoflurane, Fentanyl
Outcomes
Primary Outcomes
Respiratory depression
Time Frame: 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 Outcomes
- Quantified opioid consumption(24 hours following surgery)
- Pediatric Agitation Emergence Delirium (PAED) scale(24 hours following surgery)
- Face Legs Activity Cry Consolability (FLACC) scale(24 hours following surgery)
- Time until Post Anesthesia Care Unit (PACU) discharge readiness(24 hours following surgery)
- Other adverse effects(24 hours following surgery)