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Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery

RecruitingEARLY Phase 1Ages 18 Years - 65 YearsAllUniversity of Virginia
NCT06810336 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Remifentanil
  • Methadone
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Where

1 site
University of Virginia
Charlottesville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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