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Scientific title Safety and Efficacy of Intranasal Atomized Esketamine in the Perioperative Period of Thoracoscopic and Laparoscopic Esophagectomy for Esophageal Cancer: A Randomized, Double-Blind Clinical Study

Scientific title Safety and Efficacy of Intranasal Atomized Esketamine in the Perioperative Period of Thoracoscopic and Laparoscopic Esophagectomy for Esophageal Cancer: A Randomized, Double-Blind Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114909
Enrollment
Unknown
Registered
2025-12-18
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

esophageal cancer

Interventions

Physiological saline control group (CON group):Intranasal atomization of normal saline
0.5 mg/kg Esketamine group (E1 group):Intervention Intranasal atomization of 0.5mg/kg esketamine + normal saline
1.0 mg/kg Esketamine group (E2 group):Intervention Intranasal atomization of 1.0mg/kg esketamine + normal saline

Sponsors

Anhui Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 60 and 80 years, any gender; 2. ASA class II-III; 3. BMI 18-30 kg/m^2; 4. Patient or family requests esophageal cancer thoracoabdominal laparoscopic surgery under general anesthesia; 5. Able to understand and voluntarily sign the informed consent form, and willing to comply with the requirements of the trial protocol.

Exclusion criteria

Exclusion criteria: 1. Individuals allergic or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, ketamine, and other drugs or their components; 2. Patients with severe heart, lung, or kidney dysfunction, those with multiple chronic diseases who cannot tolerate surgical anesthesia, and patients with mental disorders; 3. Those with increased intracranial or intraocular pressure; 4. Individuals with a history of alcohol abuse, opioid allergy, or opioid abuse; 5. Severe nasal anatomical deformities; 6. Those with a history of mental illness or long-term use of antidepressants; 7. Patients with uncontrolled severe hypertension; 8. Other situations deemed unsuitable for enrollment by the investigator; 9. Patients with recent neurological diseases or surgery.

Design outcomes

Primary

MeasureTime frame
Ramsay sedation score at 24h postoperatively ;IL-6 level at 24h postoperatively ;VAS pain score at 6h postoperatively ;MMSE cognitive score at 24h postoperatively ;

Countries

China

Contacts

Public ContactYang Yue

Anhui Provincial Cancer Hospital

yyjudy1988@163.com+86 137 2109 9542

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026