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Efficacy and safety of dexmedetomidine combined with sufentanil for patient - controlled intravenous analgesia after lower limb fracture surgery:a multicenter study

Efficacy and safety of dexmedetomidine combined with sufentanil for patient - controlled intravenous analgesia after lower limb fracture

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004777
Enrollment
Unknown
Registered
2014-05-10
Start date
2014-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Patients with lower limb fracture

Interventions

S1 group:Sufentanil 2ug/kg + ondansetron 8mg diluted to 100ml of saline
S2 group:Sufentanil 3ug/kg+ ondansetron 8mg diluted to 100ml of saline
M1 group:Sufentanil 2ug/kg + dexmedetomidine 1.0ug/kg + ondansetron 8mg diluted to 100ml of saline
M2 group:Sufentanil 2ug/kg + dexmedetomidine 2.0ug/kg + ondansetron 8mg diluted to 100ml of saline

Sponsors

Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. ASA grade I to II; 2. Aged 20-60 years old; 3. Weight 50-100Kg.

Exclusion criteria

Exclusion criteria: 1. Chronic pain history and the history of long-term use of analgesics; 2. History of drug addiction; 3. Diabetes or family history of diabetes; 4. A history of hypertension and cardiovascular disease; 5. ECG abnormalities: sinus bradycardia or heart block; 6. Liver, kidney disease and coagulation dysfunction.

Design outcomes

Primary

MeasureTime frame
visual analogue scale, VAS;verbal rating scale VRS;Ramsay;Adverse reactions in 48h;Satisfaction for analgesis;

Secondary

MeasureTime frame
PCA effective number / total number;Sufentanil dosage at different time points;Dezocine dosage at different time points;Hours in Post-Anaesthetic Care Unit after surgery;Days in hospital after surgery;Time to pull the catheter;

Countries

China

Contacts

Public ContactZhang Ye

Second Affiliated Hospital of Anhui Medical University

zhangye_hassan@sina.com+86 13966768081

Outcome results

None listed

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