Methadone vs Remifentanil for Pain in Craniotomy Surgery

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Virginia

No Placebo Group

Trial Summary

What is the purpose of this trial?

Postoperative pain is prevalent after intracranial surgery. Patients undergoing craniotomy are typically managed with short acting opioids to enable early and reliable post-operative neurological exam as well as avoid the risk of respiratory depression. However, a plethora of studies have shown that a majority of these patients experience moderate to severe pain in first 48 hours after surgery. Suboptimal pain control can lead to complications such as arterial hypertension and post-operative intracranial hemorrhage, and hence, increased morbidity and mortality. Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery. Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery and received IV methadone intraoperatively. In a recently published retrospective study, a single intraoperative dose of IV methadone was well tolerated with lower pain scores as well as MME (oral morphine milligram equivalents) requirements for up to 72 hours after elective intracranial surgery. IV methadone has, however, never been compared with conventional management via IV remifentanil for functional recovery in patients undergoing elective intercranial surgery. The investigator's hypothesis is that intravenous (IV) methadone is non-inferior to IV remifentanil in patients who undergo elective intracranial surgery. It offers the advantage of being a single dose noninvasive analgesic modality that may contribute to decreasing MME consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery.

Research Team

Eligibility Criteria

This trial is for patients undergoing craniotomy surgery who need effective pain control post-operation. The study aims to include those who could benefit from long-lasting pain relief without the risk of respiratory depression, which is crucial after brain surgery.

Inclusion Criteria

1. Adult Patients between ages 18 and 65 years old.

2. Undergoing supratentorial intracranial surgery

3. American Society of Anesthesiologists (ASA) physiological status I-III

Treatment Details

Interventions

• Methadone (Opioid)
• Remifentanil (Opioid)

Trial Overview The trial is testing whether a single dose of IV methadone can manage pain as effectively as IV remifentanil in patients after elective intracranial surgery. It's looking at how well methadone controls pain and improves recovery compared to the standard opioid treatment.

Participant Groups

Group I: IV Methadone Experimental Treatment 1 Intervention

0.2 mg / kg Intravenous delivery prior to incision

Group II: IV Remifentanil Active Control 1 Intervention

titratable medication, dosage determined by anesthesia care team.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia