Trial Outcomes & Findings for A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery. (NCT NCT04562597)
NCT ID: NCT04562597
Last Updated: 2023-02-14
Results Overview
Post operative opioid consumption in the 12 hours that occur post-operatively.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
12 hours
Results posted on
2023-02-14
Participant Flow
Participant milestones
| Measure |
Period 1: NAC (0mg/kg)
(n=5) 5 participants randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.
|
Period 1: NAC (50mg/kg)
(n=5) 5 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.
|
Period 1: NAC (100mg/kg)
(n=5) 5 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.
|
Period 1: NAC (150mg/kg)
(n=5) 5 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose.
|
Period 2: NAC (0mg/kg)
(n=15) 15 additional participants randomized to placebo
|
Period 2: NAC (150mg/kg)
(n=15) Since optimal not identified with dose response curve, 15 more subjects enrolled in 150 mg/kg group for final comparison with placebo.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
15
|
15
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.
Baseline characteristics by cohort
| Measure |
NAC (0mg/kg)
n=20 Participants
(n=20) 5 participants randomized to the placebo group to estimate the dose response curve and to identify the optimal dose. Then 15 more patients enrolled for final comparison versus optimal dose.
|
NAC (50mg/kg)
n=5 Participants
(n=5) 5 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.
|
NAC (100mg/kg)
n=5 Participants
(n=5) 5 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.
|
NAC (150mg/kg)
n=20 Participants
(n=20) 5 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose. Since optimal not identified with dose response curve, 15 more subjects enrolled in 150 mg/kg group for final comparison with placebo.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 8.21 • n=7 Participants
|
71.6 years
STANDARD_DEVIATION 7.54 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 6.62 • n=4 Participants
|
64.4 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
20 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
Home opioid use (yes)
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
13 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 hoursPopulation: Primary and secondary outcomes were only be evaluated for the placebo and optimal NAC groups. Data are reported as mean (95% CI) estimated from a linear mixed model of opioid consumption over time including main effects for treatment group, postoperative time, and the interaction between treatment group and postoperative time and a random subject effect.
Post operative opioid consumption in the 12 hours that occur post-operatively.
Outcome measures
| Measure |
Placebo
n=20 Participants
NAC 0 mg/kg
|
N-acetylcysteine (NAC)
n=20 Participants
N-acetylcysteine (NAC)150 mg/kg
|
|---|---|---|
|
Opioid Consumption 12 Hours Post Operative
|
19.4 IV morphine mg equivalents
Interval 10.8 to 28.0
|
15.6 IV morphine mg equivalents
Interval 7.02 to 24.2
|
SECONDARY outcome
Timeframe: 6-48 hoursPopulation: Primary and secondary outcomes were only be evaluated for the placebo and optimal NAC groups. Data are reported as mean (95% CI) estimated from a linear mixed model of opioid consumption over time including main effects for treatment group, postoperative time, and the interaction between treatment group and postoperative time and a random subject effect.
Post operative opioid consumption ry 6 hours post operative. Data are reported as mean (95% CI) or mean difference (95% CI) estimated from a linear mixed model of opioid consumption over time including main effects for treatment group, postoperative time, and the interaction between treatment group and postoperative time and a random subject effect.
Outcome measures
| Measure |
Placebo
n=20 Participants
NAC 0 mg/kg
|
N-acetylcysteine (NAC)
n=20 Participants
N-acetylcysteine (NAC)150 mg/kg
|
|---|---|---|
|
Opioid Consumption Every 6 Hours Post Operative
6 hours
|
14.6 IV morphine mg equivalents
Interval 5.97 to 23.1
|
12.0 IV morphine mg equivalents
Interval 3.43 to 20.6
|
|
Opioid Consumption Every 6 Hours Post Operative
18 hours
|
25.0 IV morphine mg equivalents
Interval 16.4 to 33.6
|
19.9 IV morphine mg equivalents
Interval 11.3 to 28.5
|
|
Opioid Consumption Every 6 Hours Post Operative
24 hours
|
29.6 IV morphine mg equivalents
Interval 21.0 to 38.2
|
24.7 IV morphine mg equivalents
Interval 16.2 to 33.3
|
|
Opioid Consumption Every 6 Hours Post Operative
30 hours
|
34.0 IV morphine mg equivalents
Interval 25.4 to 42.6
|
27.2 IV morphine mg equivalents
Interval 18.7 to 35.8
|
|
Opioid Consumption Every 6 Hours Post Operative
36 hours
|
37.9 IV morphine mg equivalents
Interval 29.4 to 46.5
|
29.7 IV morphine mg equivalents
Interval 21.1 to 38.3
|
|
Opioid Consumption Every 6 Hours Post Operative
42
|
40.9 IV morphine mg equivalents
Interval 32.3 to 49.5
|
33.1 IV morphine mg equivalents
Interval 24.5 to 41.7
|
|
Opioid Consumption Every 6 Hours Post Operative
48
|
43.3 IV morphine mg equivalents
Interval 34.7 to 51.0
|
34.9 IV morphine mg equivalents
Interval 26.4 to 43.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NAC 50 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NAC 100 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NAC 150 mg/kg
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