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

University of Saskatchewan

Status and phase: Completed; Phase 3

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02987985

BIO 16-255

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Opioid-free anesthesia

Experimental group

Description:

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

Treatment:

Drug: Sevoflurane

Drug: Acetaminophen, gabapentin

Drug: Dexamethasone , Ondansetron

Drug: Ketamine , Lidocaine , Dexmedetomidine

Opioid-sparing anesthesia

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl, Dexmedetomidine

Drug: Sevoflurane, Fentanyl

Drug: Dexamethasone , Ondansetron

Drug: Acetaminophen