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Efficacy and safety of different doses of hydromorphone hydrochloride for postoperative intravenous controlled analgesia

Efficacy and safety of different doses of hydromorphone hydrochloride for postoperative intravenous controlled analgesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082567
Enrollment
Unknown
Registered
2024-04-01
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Postoperative analgesia in patients undergoing orthopedic surgery under general anesthesia

Interventions

The Sufentanil group:Sufentanil 2 µg/kg+ Palonosetron 4 µg/kg
Low dose hydromorphone group:Hydromorphone 0.2 mg/kg+ palonosetron 4 µg/kg
High dose hydromorphone group:Hydromorphone 0.3 mg/kg+ Palonosetron 4 µg/kg

Sponsors

Nanjing Jiangning Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
23 Years to 64 Years

Inclusion criteria

Inclusion criteria: ?Patients undergoing elective orthopedic surgery under general anesthesia ? Aged 23-64 years ?ASA I or II ?BMI 22~28 kg/m^2

Exclusion criteria

Exclusion criteria: ? Preoperative heart, liver, lung or renal insufficiency ?Have diabetes, nervous system disease, blood system disease or immune system disease ?Have mental disorders, hearing or speech disorders ?A history of chronic pain ?Have a long history of taking psychotropic drugs or analgesic drugs ?A history of drug or alcohol dependence ?Have a history of depression ?Preoperative anxiety score (SAS) =50 points or depression score (SDS) =53 points ?Have a long history of sleep disorders or preoperative Pittsburgh Sleep Quality Index Scale (PSQI) score >15

Design outcomes

Primary

MeasureTime frame
Resting Visual Analogue Score at 6 h after surgery;Incidence of dizziness and lethargy at 48 h after surgery;

Secondary

MeasureTime frame
Resting Visual Analogue Score at 2,12,24, and 48 h after surgery;Total number of compressions, effective compressions and number of rescue analgesia within 48 h;Postoperative awakening time, extubation time, and hospital stay;Sedation, Self-rating Depression Scale and Pittsburg Sleep Quality Index score at 24 and 48 h after surgery;The occurrence of nausea and vomiting , respiratory depression (SpO 2 <90%) and skin pruritus within 48 h after surgery.;

Countries

China

Contacts

Public ContactWang Wei

Nanjing Jiangning Hospital

278614725@qq.com+86 138 5188 5625

Outcome results

None listed

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