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

Anesthesia Clinical Trial

Official title:

Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987985
• Other study ID #: BIO 16-255
• Status: Completed
• Phase: Phase 3
• Start date: October 15, 2017
• Est. completion date: December 20, 2020

Study information

• Verified date: August 2021
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 20, 2020
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesics
• Analgesics, Opioid
• Anesthesia
• Depression
• Depressive Disorder
• Dexmedetomidine
• Gabapentin
• General Anesthesia
• Ketamine
• Lidocaine
• Narcotics
• Obstructive Sleep Apnea of Child
• Pathologic Processes
• Physiologic Effects of Drugs
• Postoperative Complications
• Pulse Oximetry
• Respiratory Depression
• Respiratory Insufficiency
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing
• Tonsillectomy

Intervention

Drug:
• Acetaminophen, gabapentin
acetaminophen 15 mg/kg, gabapentin 10 mg/kg
• Acetaminophen
acetaminophen 15 mg/kg
• Ketamine , Lidocaine , Dexmedetomidine
Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg
• Fentanyl, Dexmedetomidine
Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg
• Dexamethasone , Ondansetron
Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg
• Sevoflurane
Sevoflurane (dose titrated to effect)
• Sevoflurane, Fentanyl
Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours following surgery
Secondary	Quantified opioid consumption	Quantified opioid consumption	24 hours following surgery
Secondary	Pediatric Agitation Emergence Delirium (PAED) scale	Pediatric Agitation Emergence Delirium (PAED) scale	24 hours following surgery
Secondary	Face Legs Activity Cry Consolability (FLACC) scale	Face Legs Activity Cry Consolability (FLACC) scale	24 hours following surgery
Secondary	Time until Post Anesthesia Care Unit (PACU) discharge readiness	Time until Post Anesthesia Care Unit (PACU) discharge readiness	24 hours following surgery
Secondary	Other adverse effects	Other adverse effects	24 hours following surgery