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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Adult Patients between ages 18 and 65 years old.

• Undergoing supratentorial intracranial surgery

• American Society of Anesthesiologists (ASA) physiological status I-III

• Body Mass Index (BMI) between 18.5 and 45

• Ability to understand and read English

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Jennifer Phillips, RN
JVP8A@virginia.edu
434-297-8136
Backup
Lauren Dunn, M.D.
lak3r@uvahealth.org
434-924-2283
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2027-09-10
Participants
Target number of participants: 40
Treatments
Active_comparator: IV Remifentanil
titratable medication, dosage determined by anesthesia care team.
Experimental: IV Methadone
0.2 mg / kg Intravenous delivery prior to incision
Related Therapeutic Areas
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov