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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: Recruiting Early Phase 1 study, sponsored by University of Virginia.

NCT06810336 is a Early Phase 1 study that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 40 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The Quality of Recovery-15 (QoR-15) scale is a patient-reported outcome measurement of the quality of recovery after surgery and anesthesia. The scale ranges from 0 to 150, with a higher score indicating a better quality of recovery. A score of 0 indicates extremely poor quality of recovery, while a score of 150 indicates excellent quality of recovery. The QoR-15 score can be classified into four severity classes: excellent, good, moderate, and poor recovery.

Interventions

  • DRUG Methadone
  • DRUG Remifentanil

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-03-10
Est. Completion 2027-09-10
Phase Early Phase 1
University of Virginia

449 total trials

What NCT06810336 shows while recruiting

NCT06810336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.

NCT06810336 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT06810336's enrollment target sits among peer trials

40 629th of 2000 higher than 1,313 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06810336, the US trial registry maintained by the National Library of Medicine. NCT06810336 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.