Effect of different doses of esketamine combined with sufentanil on patient-controlled intravenous analgesia after laparoscopic radical resection of colorectal cancer: a randomized, double-blind, parallel-controlled trial

Effect of different doses of esketamine combined with sufentanil on postoperative patient-controlled intravenous analgesia in patients undergoing laparoscopic radical resection of colorectal cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600126992

Enrollment

Unknown

Registered

2026-06-22

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Colorectal Malignancy

Interventions

Sufentanil group:PCIA solution formulation: sufentanil 2 µg/kg + granisetron 2 mg, diluted with normal saline to a total volume of 100 mL.

Esketamine 0.5 mg/kg/48 h combined with sufentanil group:PCIA solution formulation: sufentanil 2 µg/kg + esketamine 0.5 mg/kg + granisetron 2 mg, diluted with normal saline to a total volume of 100 mL

Esketamine 1 mg/kg/48 h combined with sufentanil group:PCIA solution formulation: sufentanil 2 µg/kg + esketamine 1 mg/kg + granisetron 2 mg, diluted with normal saline to a total volume of 100 mL

Esketamine 2 mg/kg/48 h combined with sufentanil group:PCIA solution formulation: sufentanil 2 µg/kg + esketamine 2 mg/kg + granisetron 2 mg, diluted with normal saline to a total volume of 100 mL

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective laparoscopic radical resection of colorectal cancer under general anesthesia (patients undergoing the Miles procedure were excluded due to the extent of surgical trauma); 2. Aged 18 to 65 years; 3. ASA physical status classification I–III; 4. BMI 18–30 kg/m²; 5. Fully informed about the clinical trial and voluntarily participated after signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of chronic pain; 2. Patients with long-term abuse of analgesic or psychotropic drugs; 3. Patients with mental illness or a history of psychiatric disorders; 4. Patients with other severe systemic diseases (severe cardiac, renal, hepatic, or pulmonary diseases); 5. Patients with contraindications to esketamine (such as severe hypertension, intracranial hypertension, pulmonary hypertension, glaucoma, etc.); 6. Pregnant or lactating women; 7. Patients with body weight < 40 kg; 8. Patients with psychological or other emotional problems that may invalidate informed consent, poor compliance, or difficulty cooperating with treatment and follow-up.

Design outcomes

Primary

Measure	Time frame
NRS at rest and NRS on movement;Incidence of postoperative adverse events (including nausea and vomiting, delirium, hypotension, respiratory depression, pruritus, etc.);	—

Secondary

Measure	Time frame
Beck Depression Inventory-II (BDI-II);Athens Insomnia Scale (AIS) score;Total PCA pump demands, number of successful deliveries, and requirement for rescue analgesia;Mini-Mental State Examination (MMSE) score;Richmond Agitation-Sedation Scale (RASS) score;Quality of Recovery-15 (QoR-15) score;	—

Countries

China

Contacts

Public ContactXianwen Hu

The Second Affiliated Hospital of Anhui Medical University

efy110302@fy.ahmu.edu.cn+86 551 6386 9625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026