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Effects of Opioid-Free Anesthesia versus Intra-Operative Opioids Anesthesia on Postoperative Sleep Disturbance after Robot-Assisted Radical Prostatectomy: a Prospective, Single-Blind, Randomized Controlled Single-Center Clinical Trial

Effects of Opioid-Free Anesthesia versus Intra-Operative Opioids Anesthesia on Postoperative Sleep Disturbance after Robot-Assisted Radical Prostatectomy: a Prospective, Single-Blind, Randomized Controlled Single-Center Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101504
Enrollment
Unknown
Registered
2025-04-25
Start date
2024-08-29
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Prostate Cancer

Interventions

Intra-operative opioids anesthesia group:Intra-operative opioids anesthesia
Opioid-free anesthesia group:Opioid-free anesthesia

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-80 years; 2.ASA I-III classification, BMI 18-30 kg/m²; 3.Patients undergoing elective robot-assisted laparoscopic radical prostatectomy for prostate cancer; 4.Surgery and general anesthesia time >= 2 hours, postoperative hospital stay >= 3 days; 5.Patients voluntarily participated and signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of abdominal surgery; 2.Patients currently taking analgesics, sedatives, antidepressants, or hormonal medications, or those allergic to local anesthetics or other medications; 3.Patients with contraindications to epidural puncture; 4.Patients with poor general condition and a history of severe cardiovascular, respiratory, hepatic, renal, or central nervous system diseases, who may not survive for more than 3 months; 5.Patients who are unable to undergo long-term follow-up or have poor compliance; 6.Patients with poorly controlled preoperative blood pressure, with baseline preoperative blood pressure >180/100 mmHg; 7.Patients who have previously participated in the study (patients requiring re-operation during the study period).

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative sleep disturbance;

Secondary

MeasureTime frame
Postoperative anxiety and depression scores;Postoperative nausea and vomiting (at PACU discharge, 24 hours postoperatively, and 48 hours postoperatively);Patient PONV (Postoperative Nausea and Vomiting) score;Postoperative pain (at PACU discharge, 24 hours postoperatively, and 48 hours postoperatively);Patient NRS (Numeric Rating Scale) score at rest and during activity (coughing);Incidence of intraoperative hypotension;PACU stay duration;perioperative complications;gastrointestinal recovery;hospital stay duration;

Countries

China

Contacts

Public ContactDongtai Chen

Sun Yat-sen University Cancer Center

chendt@sysucc.org.cn+86 136 3137 3862

Outcome results

None listed

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