The Effect of Adding Esketamine to Postoperative Epidural Analgesia for Pain Relief in Open Gynecological Malignant Tumor Surgery: A Prospective, Randomized, Double-Blind, Parallel-Controlled Study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400091875

Enrollment

Unknown

Registered

2024-11-05

Start date

2024-11-05

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Postoperative analgesic after open gynecological malignant tumor surgery

Interventions

Control group:PCEA(300mg ropivacaine +100ug sufentanil combined with normal saline to 200ml)

Text group:PCEA(0.4mg/kg esketamine +300mg ropivacaine +100ug sufentanil combined with normal saline to 200ml)

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ?Aged >=18 and age<= 70 ?ASA I-III; ?Patients undergoing open gynecological malignant tumor surgery; ?BMI<35kg/m^2 .

Exclusion criteria

Exclusion criteria: ?Incapable of signing informed consent or communicating effectively. ?Poorly controlled hypertension (preoperative blood pressure > 180/110 mmHg). ?Coagulation dysfunction. ?Contraindications for epidural anesthesia. ?High intraocular pressure, glaucoma. ?Known or suspected schizophrenia. ?Severe coronary heart disease, history of myocardial infarction within the last 6 months, or recent chest pain with mild exertion.

Design outcomes

Primary

Measure	Time frame
Pain score on the third postoperative day.;	—

Secondary

Measure	Time frame
Pain scores on the first postoperative days.;The start time of surgery;Record the quality of recovery score on the third postoperative day for the patient;Record the patient's sleep duration on the third postoperative days.;The duration of surgery;The patient's pain score in the PACU;Patient's medication use in the PACU;Record the number of successful attempts at patient-controlled analgesia (PCA) activations postoperatively.;Record the number of failed attempts at patient-controlled analgesia (PCA) activations postoperatively.;Record the patient's sleep efficiency on the third and fourth postoperative days.;Dizziness related to esketamine;nystagmus related to esketamine;psychiatric symptoms related to esketamine;hallucinations related to esketamine;Pain scores on the second postoperative days.;Pain scores on the fourth postoperative days.;Record the patient's sleep duration on the fourth postoperative days.;Record the patient's sleep efficiency on the fourth postoperative days.;	—

Measure

Time frame

Pain scores on the first postoperative days.;The start time of surgery;Record the quality of recovery score on the third postoperative day for the patient;Record the patient's sleep duration on the third postoperative days.;The duration of surgery;The patient's pain score in the PACU;Patient's medication use in the PACU;Record the number of successful attempts at patient-controlled analgesia (PCA) activations postoperatively.;Record the number of failed attempts at patient-controlled analgesia (PCA) activations postoperatively.;Record the patient's sleep efficiency on the third and fourth postoperative days.;Dizziness related to esketamine;nystagmus related to esketamine;psychiatric symptoms related to esketamine;hallucinations related to esketamine;Pain scores on the second postoperative days.;Pain scores on the fourth postoperative days.;Record the patient's sleep duration on the fourth postoperative days.;Record the patient's sleep efficiency on the fourth postoperative days.;

—

Countries

China

Contacts

Public ContactZhang Jun

Fudan University Shanghai Cancer Center

snapzhang@aliyun.com+86 138 1715 3025

Outcome results

None listed

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