NCT06810336 Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery
| NCT ID | NCT06810336 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Virginia |
| Condition | Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2027-09-10 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-03-10 with a primary completion date of 2027-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 4. Body Mass Index (BMI) between 18.5 and 45 5. Ability to understand and read English Exclusion Criteria: 1. Being unable or unwilling to sign a consent 2. Anticipated discharge within 24 hours after surgery 3. Patients requiring Emergent Surgery 4. Preoperative usage of Methadone, or allergy to it. 5. Patients with chronic pain, requiring daily opioid use at the time of surgery, MME \>60 as FDA defines opioid tolerant as 60 MME, long-acting forms of opioids such as fentanyl patch, oxycontin 6. Active or Prior Substance Use Disorder, undergoing active treatment with Medication of Opioid Use Disorder including methadone (once daily dosing), Buprenorphine (any formulation) and Naltrexone 7. Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg/dl), 8. Pregnancy 9. Significant liver disease (cirrhosis or hepatic failure) 10. QTc \>450 on preoperative electrocardiogram 11. Pulmonary disease necessitating home oxygen therapy 12. Inability to speak or read the English language
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06810336 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06810336 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06810336 currently recruiting?
Yes, NCT06810336 is actively recruiting participants. Contact the research team at JVP8A@virginia.edu for enrollment information.
Where is the NCT06810336 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT06810336 clinical trial?
NCT06810336 is sponsored by University of Virginia. The trial plans to enroll 40 participants.