AnesthesiaPhase 3NCT02987985
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy
A Phase 3 study testing Acetaminophen, gabapentin, Acetaminophen and Ketamine , Lidocaine , Dexmedetomidine in people with Anesthesia and General Anesthesia, run by University of Saskatchewan at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Anesthesia, General Anesthesia, Analgesics, Opioid
- What is being tested?
- Acetaminophen, gabapentin, Acetaminophen and Ketamine , Lidocaine , Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2017to 20 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study
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.
Read the 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.
- Conditions
- Anesthesia, General Anesthesia, Analgesics, Opioid, Postoperative Complications, Pathologic Processes, Physiologic Effects of Drugs
- Being tested
- Acetaminophen, gabapentin, Acetaminophen, Ketamine , Lidocaine , Dexmedetomidine, Fentanyl, Dexmedetomidine, Dexamethasone , Ondansetron
- Keywords
- Opioid-sparing, Opioid-free
- Medical subject headings
- Postoperative Complications, Pathologic Processes, Sleep Apnea Syndromes, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen, gabapentinDrug
Also called Opioid-free preoperative medications
acetaminophen 15 mg/kg, gabapentin 10 mg/kg
AcetaminophenDrug
Also called Opioid-sparing preoperative medications
acetaminophen 15 mg/kg
Ketamine , Lidocaine , DexmedetomidineDrug
Also called Opioid-free pre-intubation medications
Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg
Fentanyl, DexmedetomidineDrug
Also called Opioid sparing pre-intubation medications
Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg
Dexamethasone , OndansetronDrug
Also called Postoperative nausea and vomiting prophylaxis
Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg
SevofluraneDrug
Also called Opioid-free maintenance medication
Sevoflurane (dose titrated to effect)
Sevoflurane, FentanylDrug
Also called Opioid-sparing maintenance medications
Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)
| Study group | Role | What they receive |
|---|---|---|
| Opioid-free anesthesia | Experimental | Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis Receives: 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 Receives: Drug: Acetaminophen; Drug: Fentanyl, Dexmedetomidine; Drug: Dexamethasone , Ondansetron; Drug: Sevoflurane, Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours following surgery
Secondary outcomes (5)
Quantified opioid consumption
Quantified opioid consumption
Measured: 24 hours following surgery
Pediatric Agitation Emergence Delirium (PAED) scale
Pediatric Agitation Emergence Delirium (PAED) scale
Measured: 24 hours following surgery
Face Legs Activity Cry Consolability (FLACC) scale
Face Legs Activity Cry Consolability (FLACC) scale
Measured: 24 hours following surgery
Time until Post Anesthesia Care Unit (PACU) discharge readiness
Time until Post Anesthesia Care Unit (PACU) discharge readiness
Measured: 24 hours following surgery
Other adverse effects
Other adverse effects
Measured: 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start15 Oct 2017
- Primary completion20 Sep 2019
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Gamble, University of Saskatchewan
- Investigators
- Jon Gamble, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987985
- Sponsor's protocol ID
- BIO 16-255
- Status last verified
- Aug 2021
- First submitted
- 29 Nov 2016
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study
- ClinicalTrials.gov ID
- NCT02987985
- Acronym / sponsor ID
- BIO 16-255
- Conditions
- Anesthesia, General Anesthesia, Analgesics, Opioid, Postoperative Complications, Pathologic Processes, Physiologic Effects of Drugs
- Keywords
- Opioid-sparing, Opioid-free
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-free anesthesia | Experimental | Drug: Acetaminophen, gabapentin, Drug: Ketamine , Lidocaine , Dexmedetomidine, Drug: Dexamethasone , Ondansetron, Drug: SevofluraneOpioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis |
| Opioid-sparing anesthesia | Active comparator | Drug: Acetaminophen, Drug: Fentanyl, Dexmedetomidine, Drug: Dexamethasone , Ondansetron, Drug: Sevoflurane, FentanylOpioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen, gabapentinAlso: Opioid-free preoperative medicationsacetaminophen 15 mg/kg, gabapentin 10 mg/kg | Drug | Opioid-free anesthesia |
| AcetaminophenAlso: Opioid-sparing preoperative medicationsacetaminophen 15 mg/kg | Drug | Opioid-sparing anesthesia |
| Ketamine , Lidocaine , DexmedetomidineAlso: Opioid-free pre-intubation medicationsKetamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg | Drug | Opioid-free anesthesia |
| Fentanyl, DexmedetomidineAlso: Opioid sparing pre-intubation medicationsFentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg | Drug | Opioid-sparing anesthesia |
| Dexamethasone , OndansetronAlso: Postoperative nausea and vomiting prophylaxisDexamethasone 150 mcg/kg, Ondansetron 50 mg/kg | Drug | Opioid-free anesthesia, Opioid-sparing anesthesia |
| SevofluraneAlso: Opioid-free maintenance medicationSevoflurane (dose titrated to effect) | Drug | Opioid-free anesthesia |
| Sevoflurane, FentanylAlso: Opioid-sparing maintenance medicationsSevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion) | Drug | Opioid-sparing anesthesia |
Primary outcome
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
5 secondary outcomes
Quantified opioid consumption
Time frame: 24 hours following surgery
Pediatric Agitation Emergence Delirium (PAED) scale
Time frame: 24 hours following surgery
Face Legs Activity Cry Consolability (FLACC) scale
Time frame: 24 hours following surgery
Time until Post Anesthesia Care Unit (PACU) discharge readiness
Time frame: 24 hours following surgery
Other adverse effects
Time frame: 24 hours following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Gamble, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetaminophen, gabapentin, Acetaminophen and Ketamine , Lidocaine , Dexmedetomidine in people with Anesthesia and General Anesthesia, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory depression (time frame: 24 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.