Skip to content

Clinical study of bupivacaine in combination with fentanyl on perioperative hemodynamic changes in lower extremity orthopedic surgery in elderly patients: a multicenter, prospective, randomized, parallel-controlled study

Study on the mechanism of fentanyl-enhanced anesthesia in subarachnoid space and its application

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073519
Enrollment
Unknown
Registered
2023-07-13
Start date
2023-07-17
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Hemodynamics

Interventions

Group C:Bupivacaine
group F1 :Bupivacaine + fentanyl 25ug
group 2:Bupivacaine + fentanyl 50ug

Sponsors

Ningxia Hui Autonomous Region People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) Age = 60 years old and < 90 years old, gender and nationality are not limited; 2) ASA Grade I-III; 3) Proposed lower limb orthopedic surgery; 4) Endospinal anesthesia; 5) Agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those who refuse to participate in this study; 2) previous bed rest, schizophrenia, epilepsy, Parkinson's history or myasthenia gravis; 3) Those with coagulation dysfunction, history of spinal trauma, lumbar spine lesions that are not easy to undergo neuraxial anesthesia, puncture site infection; 4) Those who cannot communicate due to coma, severe dementia, language disorders, terminal diseases, etc. before surgery; 5) Critical condition (preoperative ASA grade =IV); Severe renal impairment (requiring renal replacement therapy) Severe liver impairment (Child-Pugh class C); severe cardiac insufficiency (NYHA= grade III.); 6) The attending physician or investigator believes that there are other circumstances that are not suitable to participate in this study. The reason needs to be documented.

Design outcomes

Primary

MeasureTime frame
Blood pressure;heart rate;Hypotension;hypertension;Bradycardia;tachycardia;Hypothermia;Respiratory depression;Hypoxemia;chill;Itching;

Secondary

MeasureTime frame
Time to onset of action of anesthesia;Anesthesia plane;Vasoactive drug use;Amount of bleeding;The amount of blood transfused;Amount of liquid;

Countries

China

Contacts

Public ContactYe Qingshan

Ningxia Hui Autonomous Region People's Hospital

yeqingshan@hotmail.com+86 173 9505 5188

Outcome results

None listed

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