Lidocaine + Dexmedetomidine for Surgery Outcomes

(OPUS Trial)

Overseen By Sophie Guay, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must not be taking: Alpha-2 agonists, Local anesthetics

Disqualifiers: Pregnancy, Severe renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two medications, dexmedetomidine (a sedative) and lidocaine (a local anesthetic), used during general anesthesia, might improve recovery after major non-cardiac surgeries. The goal is to determine if these drugs can help patients resume normal activities faster and with fewer complications. Individuals undergoing major surgeries that require an overnight hospital stay and general anesthesia might be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to medical research that could enhance recovery experiences for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you regularly use alpha-2 agonists or local anesthetics, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that intravenous lidocaine is generally safe and commonly used to manage post-surgical pain. It can reduce pain and lessen the need for strong painkillers like opioids. However, incorrect use can be dangerous, though such cases are rare.

Similarly, dexmedetomidine aids recovery after surgery by helping with pain and improving recovery quality. Some studies suggest it helps regulate heart rate and blood pressure during surgery. However, findings are mixed, with some research indicating it might negatively affect long-term survival.

Both treatments are usually well-tolerated, but like any medication, they carry some risks. Discuss potential side effects with a healthcare professional before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the potential of using dexmedetomidine and lidocaine during surgery because they offer a unique approach to improving surgical outcomes. Unlike typical anesthesia protocols that focus solely on sedation and pain management, dexmedetomidine has sedative and analgesic effects while also providing anxiolytic and sympatholytic benefits, which can lead to a more stable cardiovascular response during surgery. Lidocaine, on the other hand, is known for its local anesthetic properties but also has anti-inflammatory and pain-relieving effects that can reduce the need for opioids post-surgery. This combination could enhance patient recovery by minimizing pain and reducing opioid consumption, which is a significant advancement over conventional anesthesia practices.

What evidence suggests that this trial's treatments could be effective for improving recovery after major surgery?

Research has shown that intravenous lidocaine, which participants in this trial may receive, can greatly reduce pain and the need for opioids after surgery. In one study, 88.3% of patients experienced less moderate-to-severe pain within 24 hours after their surgery. Similarly, dexmedetomidine, another treatment option in this trial, has shown promise in aiding recovery after surgery. It not only helps with pain relief but also improves mental functions like thinking and memory. Studies indicate it reduces complications and enhances overall recovery. Both treatments offer potential benefits for a smoother recovery after surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

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

Alexis Turgeon, MD MSc FRCPC

Principal Investigator

CHU de Quebec-Université Laval Research Center

Are You a Good Fit for This Trial?

This trial is for patients undergoing major non-cardiac surgery who may benefit from improved recovery strategies. It aims to test if dexmedetomidine and lidocaine given during general anesthesia can help with postoperative pain and quality of life. Specific eligibility criteria are not provided, but typically include adults in good health without conditions that would interfere with the study or pose risks.

Inclusion Criteria

Able to complete baseline quality of recovery assessment

I will need general anesthesia for my procedure.

I am scheduled for a major surgery that is not heart-related, lasting over 1.5 hours and requires at least one night in the hospital.

Exclusion Criteria

Pregnant women

No fixed address

I am not allergic to dexmedetomidine or lidocaine and do not have severe kidney, liver issues, slow heart rate, or low blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive intraoperative intravenous dexmedetomidine or lidocaine during major non-cardiac surgery

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Lidocaine

Trial Overview The OPUS Anesthesia Pilot Trial is testing whether intravenous dexmedetomidine and lidocaine administered during surgery can improve patient outcomes compared to a control group receiving standard care. The study will assess the feasibility of a larger phase 3 trial on these interventions.

How Is the Trial Designed?

Group I: Usual care Experimental Treatment 1 Intervention

Group II: Intraoperative intravenous lidocaine Experimental Treatment 1 Intervention

Group III: Intraoperative intravenous dexmedetomidine Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Canadian Perioperative Anesthesia Clinical Trials (PACT) Group

Collaborator

Trials

2

Recruited

840+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

International Anesthesia Research Society (IARS)

Collaborator

Trials

7

Recruited

1,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12165510/

Efficacy of perioperative dexmedetomidine in postoperative ... Our study demonstrates that intravenous dexmedetomidine significantly improved postoperative pain and neurocognitive functions in orthopedic surgery patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224003465

Effectiveness of dexmedetomidine on patient-centred ... Intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery.

3. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.112.000936?doi=10.1161/CIRCULATIONAHA.112.000936

Perioperative Dexmedetomidine Improves Outcomes of ... Perioperative dexmedetomidine use was associated with a decrease in postoperative mortality up to 1 year and decreased incidence of postoperative complications ...

4. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(24)00346-5/fulltext

a systematic review and Bayesian meta-analysis Compared with placebo or standard of care, intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery ...

5. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-01838-z

Intravenous infusion of dexmedetomidine during the surgery ... Intravenous DEX infusion during surgery reduces POD and POCD risk in elderly non-cardiac, non-neurosurgery patients. Continuous DEX infusion in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8517746/

Effect of Intraoperative Dexmedetomidine on Recovery of ... In this randomized clinical trial, the administration of intraoperative dexmedetomidine reduced the time to first flatus, time to first feces, ...

7. asja.springeropen.com asja.springeropen.com/articles/10.1186/s42077-022-00248-9

Effects of intravenous dexmedetomidine on perioperative ... Patients in the D group showed statistically significant attenuation of heart rate (P < 0.05) and blood pressure (P < 0.05) throughout the ...

8. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(25)00205-3/fulltext

Effect of intraoperative dexmedetomidine on prognosis in ... Retrospective studies indicated that dexmedetomidine was associated with decreased overall survival (post-matching HR 1.52, 95% CI 1.15–2.00, P= ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7223065/

Dexmedetomidine in Enhanced Recovery After Surgery ... Perioperative use of dexmedetomidine has significantly improved postoperative outcomes when used as part of ERAS protocols. An in-depth review ...