Effects of perioperative oxycodone as the sole opioid on immune function in patients undergoing gynecologic malignancy surgery based on multimodal analgesia

Effects of perioperative oxycodone as the sole opioid on immune function in patients undergoing gynecologic malignancy surgery

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068377

Enrollment

Unknown

Registered

2023-02-16

Start date

2023-02-20

Completion date

Unknown

Last updated

2023-05-22

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

Conditions

patients undergoing gynecologic malignancy surgery

Interventions

Group O:During anesthesia induction, oxycodone 0.3 mg/kg was injected intravenously.Intraoperative injection of oxycodone 0.03 mg/kg on demand to maintain analgesia

Postoperative PCIA: Oxycodone 50 mg diluted to 100 ml

Group C:During anesthesia induction, sufentanil was injected 0.3 µg/kg

Intraoperative continuous infusion of remifentanil 0.1-0.3 µg/kg/min to maintain analgesia

Postoperative PCIA: Sufentanil 50 µg diluted to 100 ml

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: aged 18 to 64 years, American Society of Anesthesiologists (ASA) grade =?, scheduled for laparoscopic gynecological malignancy surgery under general anesthesia.

Exclusion criteria

Exclusion criteria: BMI > 30 kg/m2 or =18.4 kg/m2;patients with insensitivity or high sensitivity to pain;cognitive impairment or loss of language ability;patients with severe organ or systemic diseases, such as severe hypertension (systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg), severe liver, kidney or lung dysfunction, known preoperative left ventricular ejection fraction < 30%, myasthenia gravis, hypothyroidism or hyperthyroidism, gastroduodenal ulcer, etc.allergic to the study drug;a history of alcohol abuse or drug use or addiction or long-term use of opioids or other analgesic drugs (=3 months);long-term use of antidepressants;Patients with a history of preoperative chemoradiotherapy or other diseases affecting immune function;patients who did not receive postoperative PCIA pump;postoperative recurrence of malignant tumor;and refused to participate in the study.

Design outcomes

Primary

Measure	Time frame
CD4+/CD8+ at 24 hours after surgery;	—

Secondary

Measure	Time frame
Degree of pain scored by visual analogue scale (VAS);Catheter-related bladder discomfort;	—

Countries

China

Contacts

Public ContactJingjing Liu

Obstetrics and Gynecology Hospital of Fudan University

jingjingruoxi@163.com13681743239

Outcome results

None listed

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