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

Phase 3

Completed

• Conditions: Anesthesia; General Anesthesia; Analgesics, Opioid; Postoperative Complications; Pathologic Processes; Physiologic Effects of Drugs; Narcotics; Analgesics; Sleep Disordered Breathing; Obstructive Sleep Apnea of Child
• Interventions: Drug: Acetaminophen, gabapentin; Drug: Acetaminophen; Drug: Ketamine , Lidocaine , Dexmedetomidine; Drug: Fentanyl, Dexmedetomidine; Drug: Dexamethasone , Ondansetron; Drug: Sevoflurane, Fentanyl; Drug: Sevoflurane

• Registration Number: NCT02987985
• Lead Sponsor: University of Saskatchewan

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.

Study Timeline

• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-09
• Study Start: 2017-10-15
• Primary Completion: 2019-09-20
• Study Completion: 2020-12-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid-free anesthesia	Ketamine , Lidocaine , Dexmedetomidine	Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis
Opioid-free anesthesia	Dexamethasone , Ondansetron	Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis
Opioid-sparing anesthesia	Fentanyl, Dexmedetomidine	Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
Opioid-sparing anesthesia	Sevoflurane, Fentanyl	Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
Opioid-sparing anesthesia	Dexamethasone , Ondansetron	Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
Opioid-free anesthesia	Acetaminophen, gabapentin	Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis
Opioid-sparing anesthesia	Acetaminophen	Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
Opioid-free anesthesia	Sevoflurane	Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada