Trial Outcomes & Findings for Dosing of Methadone for Spine Surgery (NCT NCT03605901)
NCT ID: NCT03605901
Last Updated: 2026-06-23
Results Overview
The milligram morphine equivalence (MME) dose was computed for each patient in each 24 hour period using IV (intravenous) administration and by mouth (PO). The outcome measure is defined as the difference between 24 hour periods in the cumulative morphine milligram equivalence dose across both IV (intravenous) administration and by mouth (PO). The difference was calculated by subtracting the MME dose value at the later time point minus the MME value at the earlier time point (e.g., value at 24 hours postop minus value at baseline).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Postop 24 hours, Postop 48 hours, Postop 72 hours
Results posted on
2026-06-23
Participant Flow
Participant milestones
| Measure |
Standard Dosing of Methadone
Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
Standard dosing of methadone: Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
|
Aliquots of Methadone Titrated to Apnea
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. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dosing of Methadone for Spine Surgery
Baseline characteristics by cohort
| Measure |
Standard Dosing of Methadone
n=10 Participants
Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
Standard dosing of methadone: Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
|
Aliquots of Methadone Titrated to Apnea
n=11 Participants
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. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed.
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 11.4 • n=20 Participants
|
62.9 years
STANDARD_DEVIATION 12.7 • n=20 Participants
|
64.3 years
STANDARD_DEVIATION 11.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=20 Participants
|
11 participants
n=20 Participants
|
21 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Postop 24 hours, Postop 48 hours, Postop 72 hoursThe milligram morphine equivalence (MME) dose was computed for each patient in each 24 hour period using IV (intravenous) administration and by mouth (PO). The outcome measure is defined as the difference between 24 hour periods in the cumulative morphine milligram equivalence dose across both IV (intravenous) administration and by mouth (PO). The difference was calculated by subtracting the MME dose value at the later time point minus the MME value at the earlier time point (e.g., value at 24 hours postop minus value at baseline).
Outcome measures
| Measure |
Standard Dosing of Methadone
n=10 Participants
Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
Standard dosing of methadone: Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
|
Aliquots of Methadone Titrated to Apnea
n=11 Participants
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. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed.
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.
|
|---|---|---|
|
Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop
Postop 24 hours
|
37.3 milligram morphine equivalence
Standard Deviation 28.1
|
68.1 milligram morphine equivalence
Standard Deviation 47.3
|
|
Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop
Postop 48 hours
|
52.8 milligram morphine equivalence
Standard Deviation 39.6
|
59.0 milligram morphine equivalence
Standard Deviation 38.0
|
|
Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop
Postop 72 hours
|
41.0 milligram morphine equivalence
Standard Deviation 39.3
|
58.0 milligram morphine equivalence
Standard Deviation 41.4
|
Adverse Events
Standard Dosing of Methadone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aliquots of Methadone Titrated to Apnea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place