NCT07264556Recruiting
Effect of OFA, OSA Versus Opioid-based Anesthesia on NETs and Cancer Cell Malignancy After Colorectal Cancer Surgery
Effect of Opioid-Free, Opioid-sparing Versus Opioid-based Anesthesia on Perioperative NETs and Cancer Cell Malignancy in Patients Undergoing Surgery for Colorectal Cancer: A Randomized, Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
Adult patients aged 18-80 years old, American Society of Anesthesiologists physical status I-III, who were scheduled for elective colorectal cancer surgery under general anesthesia were recruited for this study. They were randomized to receive opioid-free anesthesia (OFA), opioid-sparing anesthesia (OSA) and opioid-based anesthesia (OA) group. Blood samples were collected pre-surgery and 24h post-surgery. As primary endpoint, serum neutrophil myeloperoxidase (MPO) and citrullinated histone3 (CitH3) was measured. The secondary endpoints included the effects of postoperative serum on colorectal cancer (CRC) cells malignancy, numerical rating scale (NRS) scores, postoperative adverse events and recovery profiles. For OA group, intraoperative remifentanil and sufentanil were used and postoperative patient controlled intravenous analgesia (PCIA) was performed with 0.5μg/ml of sufentanil and 0.75 mg/mL flurbiprofen, and the PCIA was stopped 48 h after surgery. For OSA group, remifentanil and sufentanil were used only for anesthetic induction and the patient received ultrasound-guided transversus abdominis plane (TAP) nerve blockwas performed. Patient controlled intravenous analgesia (PCIA) was performed with 1mg/mL of oxycodone and 0.75 mg/mL flurbiprofen after surgery, and the PCIA was stopped 48 hours after surgery. For OFA group, intraoperative epidural anesthesia combined with general anesthesia was used, and esketamine, lidocaine and dexmedetomidine for analgesia. Patient controlled epidural analgesia (PCEA) was used and terminated 48 hours after surgery.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT07264556
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 1 Nov 2025 to the primary completion date, 30 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous history of colorectal surgery,
- radiotherapy or chemotherapy history within 8 weeks prior to the surgery,
Other illness
- serious major mental or physical illness (heart, pulmonary, hepatic, or renal diseases),
Other
- addicted to opioids,
- contraindications to anesthetic agents or epidural.
Who the study is looking for
- aged 18-80 years old,
- American Society of Anesthesiologists physical status I-III,
- elective colorectal cancer surgery under general anesthesia
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.