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Dosing of Methadone for Spine Surgery

NCT03605901 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-06-10

No results posted yet for this study

Summary

This study compares two methods of dosing methadone for complex spine cases

Conditions

  • Pain, Postoperative

Interventions

DRUG

Standard dosing of methadone

Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.

DRUG

Aliquots of methadone titrated to apnea

Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Christoph Seubert, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2025-05-09
Completion
2025-05-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03605901 on ClinicalTrials.gov