CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
N-acetyl cysteine +1 moredrug
Likely dose
N-acetyl cysteine 50mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04732000
NCT04732000Phase 2Completed

Oxidative Stress and Surgical Recovery

Stanford University·interventional·Posted Feb 1, 2021·Updated Apr 30, 2025

In Brief

A Phase 2 clinical trial evaluating N-acetyl cysteine and Normal Saline for Surgical Recovery and Pain, Postoperative. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Chronic pain, functional impairment and slow rates of recovery are key issues for patients after surgery and trauma. No preventative strategy in current use unequivocally modifies these rates, and few novel approaches have been tested. Furthermore, persistent postsurgical pain is a major route to chronic opioid use, opioid use disorder and, regrettably, opioid overdose. Most strategies designed to limit chronic pain or enhance functional recovery after surgery are directed at modulating peripheral and central nervous system activity and do not strongly modify the underlying tissue pathophysiology or fundamental systemic responses. Strategies limiting oxidative stress in the perioperative period, on the other hand, might limit tissue damage, organ dysfunction and immune system activation. N-acetyl cysteine (NAC) is an antioxidant well-studied in the perioperative period; it is very safe, relatively inexpensive and widely available. The central hypothesis is, therefore, that perioperative administration of NAC will reduce perioperative oxidative stress, limit immune system activation and improve key indices of surgical recovery. Although the planned work will not comprehensively address this hypothesis, it will identify the most useful tools and help the researchers estimate the required sample sizes for more definitive externally funded efforts.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 1, 2021
Enrollment StartJul 1, 2021
Primary CompletionMar 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.4 years ago

Interventions

N-acetyl cysteinedrug

Intravenous infusion started during the clinically indicated surgery at a rate of 50mg/kg over 1 hour followed by 50mg/kg over 3 hours. This will be an accumulated total of 100 mg/kg over 4 hours.

Normal Salineother

Intravenous infusion at a time and rate to mimic the active treatment. The infusion will be given over 4 hours beginning during the clinically indicated surgery