Actively Recruiting
Effect of Opioid-Free, Opioid-Sparing Versus Opioid-Based Anesthesia on Perioperative NETs and Cancer Cell Malignancy in Colorectal Cancer Surgery: A Randomized Controlled Trial
Led by Fudan University · Updated on 2025-12-04
90
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of three anesthesia methods—opioid-free anesthesia (OFA), opioid-sparing anesthesia (OSA), and opioid-based anesthesia (OA)—in adults aged 18 to 80 years undergoing elective colorectal cancer surgery under general anesthesia. The study measures blood markers related to inflammation and cancer cell behavior to understand how different anesthesia approaches might affect recovery and cancer cell malignancy. Participants are randomly assigned to one of three groups. The OA group receives intravenous propofol, remifentanil, sufentanil, and rocuronium during surgery, followed by patient-controlled intravenous analgesia (PCIA) with sufentanil and flurbiprofen after surgery. The OSA group receives similar induction drugs but combines this with a nerve block and PCIA with oxycodone and flurbiprofen post-surgery. The OFA group receives epidural anesthesia combined with general anesthesia using propofol, esketamine, lidocaine, and dexmedetomidine, with patient-controlled epidural analgesia (PCEA) after surgery. Participants will have blood samples collected before surgery and 24 hours after surgery to measure specific serum biomarkers. Researchers will also monitor pain levels, postoperative side effects such as nausea and vomiting, complications, and recovery profiles during the hospital stay and up to two days post-surgery. The epidural catheter or PCIA is removed or stopped 48 hours after surgery, and the overall study duration varies according to hospital discharge and recovery progress.
CONDITIONS
Brief Title
Effect of OFA, OSA Versus Opioid-based Anesthesia on NETs and Cancer Cell Malignancy After Colorectal Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years old
- American Society of Anesthesiologists physical status I-III
- Scheduled for elective colorectal cancer surgery under general anesthesia
You will not qualify if you...
- Previous history of colorectal surgery
- Addiction to opioids
- Serious major heart, lung, liver, or kidney diseases
- Radiotherapy or chemotherapy within 8 weeks before surgery
- Contraindications to anesthetic agents or epidural anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo elective colorectal cancer surgery under general anesthesia and receive one of three anesthesia strategies: opioid-based, opioid-sparing, or opioid-free anesthesia. This includes anesthesia induction, maintenance during surgery, and postoperative pain management through patient-controlled analgesia or epidural catheter infusion depending on the assigned group.
1 surgical visit (in-person)
Duration - From day of surgery to hospital discharge, including first 2 days post-surgery
Participants are monitored for postoperative pain levels, side effects such as nausea and vomiting, complications, and recovery profiles up to hospital discharge and during the first 2 days after surgery.
Approximately 3 visits (including assessments on day 1 and day 2 after surgery)
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
L
Lingling Gao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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