AnesthesiaOPUSNCT06884540
Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial
A study testing Dexmedetomidine and lidocaine in people with Anesthesia and Anesthesia Complication, run by CHU de Quebec-Universite Laval at 5 sites in Canada.
Trial summary
Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Anesthesia Complication, Surgery
- What is being tested?
- Dexmedetomidine and lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesCanada
- Study dates
- 15 Jul 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >/= 18 years.
- Having elective major non-cardiac surgery (i.e., planned duration >/= 1.5 hours and anticipated >/= 1 night hospital stay).
- Requiring general anesthesia.
- Able to complete baseline quality of recovery assessment.
Who cannot join
- Individuals with known contraindications to dexmedetomidine or lidocaine (e.g., allergy to alpha-2 agonists or local anesthetics, severe renal or hepatic failure, bradycardia or hypotension), as per routine assessment.
- Regular use of alpha-2 agonists or local anesthetics prior to hospitalization.
- Pregnant women.
- Planned use of regional analgesia (i.e., epidural, peripheral nerve block, trunk nerve block) in conjunction with general anesthesia. Local anesthetics such as lidocaine are administered as part of regional analgesia technique. Combination with intravenous lidocaine is contraindicated to avoid exceeding therapeutic concentration.
- Neurosurgical procedures except for spine surgery.
- Planned postoperative intubation after PACU discharge.
- No fixed address.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
CISSS de Chaudière-Appalaches (Hôtel-Dieu de Lévis)
Lévis, Quebec, G6V3Z1
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1
Royal Columbian Hospital
New Westminster, British Columbia, V3L 0A2
CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus)
Québec, Quebec, G1J 1Z4
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
About this study
Official title: Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies (OPUS) Anesthesia: a Pilot Randomised Controlled Trial
Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.
- Conditions
- Anesthesia, Anesthesia Complication, Surgery, Quality of Life, Pain, Postoperative, Anesthesia Morbidity
- Being tested
- Dexmedetomidine, lidocaine, control group
- Keywords
- Pilot trial, Anesthesia, Quality of recovery, Postoperative pain, Opioid minimization strategies, Dexmedetomidine, Lidocaine, Patient-centred outcomes
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intravenous bolus: between 0.2 and 0.5 mcg/kg.
followed by
Intravenous infusion: ranging from 0.2 to 0.7 mcg/kg/h to the discretion of the attending anesthesiologist.
Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure.
lidocaineDrug
Intravenous bolus: between 0.5 and 1.5 mg/kg.
followed by
Intravenous infusion: ranging from 0.5 to 2.0 mg/kg/h to the discretion of the attending anesthesiologist.
Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure.
control groupOther
Usual care where systemic dexmedetomidine is not allowed and systemic lidocaine is permitted only for the prevention or treatment of propofol injection pain.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative intravenous dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Intraoperative intravenous lidocaine | Experimental | Not described Receives: Drug: lidocaine |
| Usual care | Other | Not described Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients who are approached to participate by the study team and who consent to participate in the study.
Measured: 1 week
Secondary outcomes (4)
Proportion of participants receiving dexmedetomidine
Proportion of patients in the dexmedetomidine group who receive per protocol treatment (i.e. they receive dexmedetomidine during general anesthesia).
Measured: 24 hours
Proportion of participants receiving lidocaine
Proportion of patients in the lidocaine group who receive per protocol treatment (i.e. they receive lidocaine during general anesthesia).
Measured: 24 hours
Completeness of data collection for outcome measures
Completeness of data collection, defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point for each instrument and participant.
Measured: 6 months
Sex representativeness of participants
Proportion of female participants enrolled in the trial.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Jul 2025
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Perioperative Anesthesia Clinical Trials (PACT) Group, Canadian Institutes of Health Research (CIHR), International Anesthesia Research Society (IARS)
- Responsible party
- Sponsor
- Investigators
- Michael Verret, MD PhD FRCPC, Principal investigator, CHU de Quebec-Université Laval Research CenterDean A. Fergusson, PhD, Principal investigator, Ottawa Hospital Research InstituteManoj M. Lalu, MD PhD FRCPC, Principal investigator, Ottawa Hospital Research InstituteAlexis Turgeon, MD MSc FRCPC, Principal investigator, CHU de Quebec-Université Laval Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884540
- Sponsor's protocol ID
- OMS-162
- Acronym
- OPUS
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies (OPUS) Anesthesia: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06884540
- Acronym / sponsor ID
- OPUS / OMS-162
- Conditions
- Anesthesia, Anesthesia Complication, Surgery, Quality of Life, Pain, Postoperative, Anesthesia Morbidity
- Keywords
- Pilot trial, Anesthesia, Quality of recovery, Postoperative pain, Opioid minimization strategies, Dexmedetomidine, Lidocaine, Patient-centred outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Perioperative Anesthesia Clinical Trials (PACT) Group, Canadian Institutes of Health Research (CIHR), International Anesthesia Research Society (IARS)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Mar 2025 (actual)
- 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.
Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intraoperative intravenous dexmedetomidine | Experimental | Drug: Dexmedetomidine |
| Intraoperative intravenous lidocaine | Experimental | Drug: lidocaine |
| Usual care | Other | Other: control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults >/= 18 years.
- Having elective major non-cardiac surgery (i.e., planned duration >/= 1.5 hours and anticipated >/= 1 night hospital stay).
- Requiring general anesthesia.
- Able to complete baseline quality of recovery assessment.
Key exclusion criteria (7 listed)
- Individuals with known contraindications to dexmedetomidine or lidocaine (e.g., allergy to alpha-2 agonists or local anesthetics, severe renal or hepatic failure, bradycardia or hypotension), as per routine assessment.
- Regular use of alpha-2 agonists or local anesthetics prior to hospitalization.
- Pregnant women.
- Planned use of regional analgesia (i.e., epidural, peripheral nerve block, trunk nerve block) in conjunction with general anesthesia. Local anesthetics such as lidocaine are administered as part of regional analgesia technique. Combination with intravenous lidocaine is contraindicated to avoid exceeding therapeutic concentration.
- Neurosurgical procedures except for spine surgery.
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 |
|---|---|---|
| DexmedetomidineIntravenous bolus: between 0.2 and 0.5 mcg/kg. followed by Intravenous infusion: ranging from 0.2 to 0.7 mcg/kg/h to the discretion of the attending anesthesiologist. Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure. | Drug | Intraoperative intravenous dexmedetomidine |
| lidocaineIntravenous bolus: between 0.5 and 1.5 mg/kg. followed by Intravenous infusion: ranging from 0.5 to 2.0 mg/kg/h to the discretion of the attending anesthesiologist. Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure. | Drug | Intraoperative intravenous lidocaine |
| control groupUsual care where systemic dexmedetomidine is not allowed and systemic lidocaine is permitted only for the prevention or treatment of propofol injection pain. | Other | Usual care |
Primary outcome
Recruitment rate
Time frame: 1 week
Number of patients who are approached to participate by the study team and who consent to participate in the study.
4 secondary outcomes
Proportion of participants receiving dexmedetomidine
Time frame: 24 hours
Proportion of participants receiving lidocaine
Time frame: 24 hours
Completeness of data collection for outcome measures
Time frame: 6 months
Sex representativeness of participants
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Michael Verret, MD PhD FRCPC principal investigator
CHU de Quebec-Université Laval Research Center
Dean A. Fergusson, PhD principal investigator
Ottawa Hospital Research Institute
Manoj M. Lalu, MD PhD FRCPC principal investigator
Ottawa Hospital Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and lidocaine in people with Anesthesia and Anesthesia Complication, run by CHU de Quebec-Universite Laval at 5 sites 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment rate (time frame: 1 week). 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 1 Jul 2026.