Opioid-Free Anesthesia for Enhanced Recovery and Long-Term Outcomes in Colorectal Cancer Surgery: A Multicenter Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600127664

Enrollment

Unknown

Registered

2026-07-05

Start date

2026-07-15

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

opioid-free anesthesia:Opioid-free regimen during both induction and maintenance of general anesthesia, using intravenous dexmedetomidine + esketamine

conventional opioid anesthesia:The conventional opioid anesthesia group received sufentanil and remifentanil

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18–75; 2.ASA physical status I–III; 3.Confirmed diagnosis of colorectal cancer and scheduled for elective laparoscopic radical surgery; 4.Willing to accept randomized group assignment and provide written informed consent; Able to cooperate and complete 5-year follow-up.

Exclusion criteria

Exclusion criteria: 1.Allergy or contraindication to esketamine or dexmedetomidine; 2.Pre-existing severe cardiac, hepatic, pulmonary, or renal diseases, or immunodeficiency; 3.History of major abdominal surgery and long-term opioid or analgesic dependence due to chronic pain; 4.Psychiatric disorders (e.g., schizophrenia), epilepsy, Parkinson's disease, or long-term use of hypnotics/sedatives.

Design outcomes

Primary

Measure	Time frame
Quality of Recovery (QoR-15) score;	—

Secondary

Measure	Time frame
Time to first ambulation/oral intake;Postoperative 3-year and 5-year disease-free survival and overall survival rates;Length of postoperative hospital stay;Incidence of chronic pain at 3 months, 6 months, and 1 year postoperatively;Incidence of pain VAS score > 3 at postoperative 24 h, 48 h, and 72 h, and need for rescue analgesia;Time to first flatus/defecation;Incidence of postoperative nausea and vomiting (PONV) at 0–24 h and 24–48 h postoperatively, and the requirement for antiemetic medication;Incidence of postoperative complications (Clavien–Dindo grade >=?), including ileus, anastomotic leakage, pulmonary infection, etc.;Postoperative 24-h plasma IL-6, TNF-a, NK activity, CD4/CD8 ratio;	—

Measure

Time frame

Time to first ambulation/oral intake;Postoperative 3-year and 5-year disease-free survival and overall survival rates;Length of postoperative hospital stay;Incidence of chronic pain at 3 months, 6 months, and 1 year postoperatively;Incidence of pain VAS score > 3 at postoperative 24 h, 48 h, and 72 h, and need for rescue analgesia;Time to first flatus/defecation;Incidence of postoperative nausea and vomiting (PONV) at 0–24 h and 24–48 h postoperatively, and the requirement for antiemetic medication;Incidence of postoperative complications (Clavien–Dindo grade >=?), including ileus, anastomotic leakage, pulmonary infection, etc.;Postoperative 24-h plasma IL-6, TNF-a, NK activity, CD4/CD8 ratio;

—

Countries

China

Contacts

Public ContactPeng Ke

The First Affiliated Hospital of Soochow University

pengke0422@163.com+86 512 67780156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026