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

NCT02987985 | Completed Phase 3

• 1 other identifier: BIO 16-255
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Opioid-sparing; Opioid-free

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Opioid-free anesthesia

EXPERIMENTAL

Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis

Drug: Acetaminophen, gabapentin; Drug: Ketamine , Lidocaine , Dexmedetomidine; Drug: Dexamethasone , Ondansetron; Drug: Sevoflurane

Opioid-sparing anesthesia

ACTIVE COMPARATOR

Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis

Drug: Acetaminophen; Drug: Fentanyl, Dexmedetomidine; Drug: Dexamethasone , Ondansetron; Drug: Sevoflurane, Fentanyl

Interventions

Acetaminophen, gabapentin DRUG

acetaminophen 15 mg/kg, gabapentin 10 mg/kg

Also known as: Opioid-free preoperative medications

Opioid-free anesthesia

Acetaminophen DRUG

acetaminophen 15 mg/kg

Also known as: Opioid-sparing preoperative medications

Opioid-sparing anesthesia

Ketamine , Lidocaine , Dexmedetomidine DRUG

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

Also known as: Opioid-free pre-intubation medications

Opioid-free anesthesia

Fentanyl, Dexmedetomidine DRUG

Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg

Also known as: Opioid sparing pre-intubation medications

Opioid-sparing anesthesia

Dexamethasone , Ondansetron DRUG

Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg

Also known as: Postoperative nausea and vomiting prophylaxis

Opioid-free anesthesia; Opioid-sparing anesthesia

Sevoflurane DRUG

Sevoflurane (dose titrated to effect)

Also known as: Opioid-free maintenance medication

Opioid-free anesthesia

Sevoflurane, Fentanyl DRUG

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

Also known as: Opioid-sparing maintenance medications

Opioid-sparing anesthesia

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Postoperative Complications; Pathologic Processes; Sleep Apnea Syndromes; Respiratory Insufficiency

Interventions

Acetaminophen; Gabapentin; Ketamine; Lidocaine; Dexmedetomidine; Fentanyl; Dexamethasone; Ondansetron; Sevoflurane

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Jon Gamble, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 9, 2016
• Study Start: October 15, 2017
• Primary Completion: September 20, 2019
• Study Completion: December 20, 2020
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)