Comparing IV methadone versus IV remifentanil for pain and recovery after craniotomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, early phase 1 interventional trial randomly compares intraoperative IV methadone to IV remifentanil in adult patients undergoing elective supratentorial craniotomy. Participants receive one of the two opioid strategies during surgery and are followed for postoperative pain scores, opioid consumption (MME), nausea/vomiting, and recovery parameters for the early postoperative period. The trial excludes patients on chronic high-dose opioids, those with active substance use disorder, methadone exposure or allergy, emergent surgeries, or significant renal impairment. Safety monitoring emphasizes neurologic exam reliability and respiratory depression given the different opioid profiles.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Study coordinator: Jennifer Phillips, RN
• Email: JVP8A@virginia.edu
• Phone: 434-297-8136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.