NCT07264556 Effect of OFA, OSA Versus Opioid-based Anesthesia on NETs and Cancer Cell Malignancy After Colorectal Cancer Surgery
| NCT ID | NCT07264556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-11-01 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * aged 18-80 years old, * American Society of Anesthesiologists physical status I-III, * elective colorectal cancer surgery under general anesthesia Exclusion Criteria: * previous history of colorectal surgery, * addicted to opioids, * serious major mental or physical illness (heart, pulmonary, hepatic, or renal diseases), * radiotherapy or chemotherapy history within 8 weeks prior to the surgery, * contraindications to anesthetic agents or epidural.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07264556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07264556 currently recruiting?
Yes, NCT07264556 is actively recruiting participants. Contact the research team at LinglingGao@aliyun.com for enrollment information.
Where is the NCT07264556 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07264556 clinical trial?
NCT07264556 is sponsored by Fudan University. The trial plans to enroll 90 participants.
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