A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 20, 2021

Primary Completion Date

May 20, 2022

Study Completion Date

May 21, 2022

Conditions
Surgery
Interventions
DRUG

Dose Response Curve Placebo

5 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.

DRUG

Dose Response Curve N-acetylcysteine 50 mg/kg

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.

DRUG

Dose Response Curve N-acetylcysteine 100 mg/kg

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.

DRUG

Dose Response Curve N-acetylcysteine 150 mg/kg

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.

DRUG

Opioid Reduction with Optimal N-acetylcysteine Dose

Once the optimal N-acetylcysteinedose is identified, 15 participants will be randomized to the optimal dose (50,100, or 150 mg/kg) to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.

DRUG

Placebo

15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.

Trial Locations (1)

29425

Medical University of South Carolina, Charleston

All Listed Sponsors
lead

Medical University of South Carolina

OTHER

NCT04562597 - A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery. | Biotech Hunter | Biotech Hunter