Effect of OFA, OSA Versus Opioid-based Anesthesia on NETs and Cancer Cell Malignancy After Colorectal Cancer Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

aged 18-80 years old,

American Society of Anesthesiologists physical status I-III,

elective colorectal cancer surgery under general anesthesia

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • OA strategy

    Other intervention

    For OA group, anesthesia induction was conducted with an intravenous targeted control infusion (TCI) of 3-4 μg/mL propofol (effect-site concentration, Marsh mode), 2-3 ng/mL remifentanil (effect-site concentration, Minto mode), 0.5 μg/kg sufentanil, and 0.6 mg/kg rocuronium. General anesthesia was maintained with a continuous TCI infusion of 3 to 4 μg/mL propofol and 1 to 2 ng/mL remifentanil, intermittently administrated sufentanil and rocuronium. Patient controlled intravenous analgesia (PCIA) was performed with 0.5μg/ml of sufentanil and 0.75 mg/mL flurbiprofen after surgery. The PCIA scheme was set with the continuous infusion rate of 4 ml/h and single bolus injection volume of 4ml. The locking time was 15 min, and the PCIA was stopped 48 h after surgery.

  • OSA stategy

    Other intervention

    For OSA group, anesthesia induction was conducted with an intravenous targeted control infusion (TCI) of 3 to 4 μg/mL propofol, 2 to 3 ng/mL remifentanil, 0.3 μg/kg sufentanil, and 0.6 mg/kg rocuronium. After intubation, the patient received ultrasound-guided transversus abdominis plane (TAP) nerve block, with 0.375% ropivacaine 40mL injection. General anesthesia maintenance was consistent with OA group. Patient controlled intravenous analgesia (PCIA) was performed with 1mg/mL of oxycodone and 0.75 mg/mL flurbiprofen after surgery. The PCIA scheme was set with the continuous infusion rate was 4 ml/h and single bolus injection of 4ml. The locking time was 15 min, and the PCIA was stopped 48 hours after surgery.

  • OFA strategy

    Other intervention

    For OFA group, before induction, an epidural catheter was inserted , and the catheter was advanced 4 cm cephalad. When the aspiration test results for blood and cerebrospinal fluid were negative, a test dose of lidocaine 1% (3 ml) was injected through the catheter. Ropivacaine (0.25%) was maintained at a rate of 5 ml/h during surgery. Anesthesia induction was conducted with an intravenous targeted control infusion (TCI) of 3-4 μg/mL propofol, 0.6 mg/kg rocuronium, 0.5mg/kg esketamine, 1mg/kg lidocaine and 0.5ug/kg dexmedetomidine. General anesthesia was maintained with a continuous TCI infusion of 3 to 4 μg/mL propofol, 1.5-mg/kg/h continuous infusion of lidocaine, 0.25 mg/kg/h continuous infusion of esketamine. At the postoperative stage, the epidural administration regimen included 0.15% ropivacaine. The continuous infusion rate was 5ml/h, with an additional 5 ml upon the patient's request, and the locking time was 15 min. The epidural catheter was removed 48 hours after surgery.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: OA groupExperimental treatment 1 intervention
Group B: OSA groupExperimental treatment 1 intervention
Group C: OFA groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

serum NETs biomarkers levels .

serum levels of neutrophil myeloperoxidase (MPO) and citrullinated histone3 (CitH3)

Time frame
Day 1 before surgery and day 1 after surgery

Secondary outcomes

1

colorectal cancer (CRC) cells malignancy

the effects of postoperative serum on CRC cells proliferation, migration and invasion

Time frame
Day 1 after surgery
2

numerical rating scale (NRS) scorespain score

numerical rating scale (NRS) scores at rest and on cough,NRS score is a scale of 0 to 10, the higher the score, the greater the degree of pain.

Time frame
Day 1 and day 2 after surgery
3

adverse event: postoperative nausea and vomiting

The incidence of the postoperative nausea and vomiting, ask the patient bedside if they have any complaints of nausea or vomiting postoperatively.

Time frame
Day 1 and day 2 after surgery
4

postoperative complications

surgical complications

Time frame
On the day of surgery to the day discharge from hospital

Other outcomes

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