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NCT06810336 · ClinicalTrials.gov registry record · Early Phase 1
Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery
A Early Phase 1 study, sponsored by University of Virginia.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
NCT06810336 is a Early Phase 1 study that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 40 participants.
The verdict
NCT06810336, a Early Phase 1 study, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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 improvin
Interventions
- DRUG Methadone
- DRUG Remifentanil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-03-10 |
| Est. Completion | 2027-09-10 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06810336
The ClinicalTrials.gov registry entry for NCT06810336 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT06810336 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06810336 about?
NCT06810336 is a clinical study titled "Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery". 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...
What is the current status of trial NCT06810336?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2025-03-10. Estimated completion is 2027-09-10.
What interventions are being tested in trial NCT06810336?
The interventions under investigation include: Methadone (DRUG), Remifentanil (DRUG).
Who is sponsoring clinical trial NCT06810336?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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