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Study on the Dose-Effect Relationship of 50µg Fentanyl Combined with Different Doses of Bupivacaine in Spinal Anesthesia for Various Types of Surgeries

Study on the Dose-Effect Relationship of 50µg Fentanyl Combined with Different Doses of Bupivacaine in Spinal Anesthesia for Various Types of Surgeries

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097018
Enrollment
Unknown
Registered
2025-02-11
Start date
2025-02-20
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Spinal Anesthesia

Interventions

B4 group:12.5mg Bupivacaine + 50µg Fentanyl
B5 group:15.0mg Bupivacaine + 50µg Fentanyl
B6 group:17.5mg Bupivacaine + 50µg Fentanyl
B1 group:5.0mg Bupivacaine + 50µg Fentanyl
B2 group:7.5mg Bupivacaine + 50µg Fentanyl
B3 group:10.0mg Bupivacaine + 50µg Fentanyl
B7 group:20.0mg Bupivacaine + 50µg Fentanyl

Sponsors

Ningxia Hui Autonomous Region People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 and 60 years old, with a Body Mass Index (BMI) ranging from 20 to 35 kg/m²; (2) Patients classified as American Society of Anesthesiologists (ASA) physical status I-II; (3) No contraindications for subarachnoid block or the use of anesthetic drugs; (4) Consent to participate in the study and having signed a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with severe neurological or neuromuscular diseases who are unable to complete the assessment; (2) Patients with infections at the injection site; (3) Patients who are pregnant or breastfeeding; (4) Patients with severe concomitant cardiac, pulmonary, renal, or hepatic diseases.

Design outcomes

Primary

MeasureTime frame
Onset time of sensory block;Duration of sensory block;Efficacy of sensory block at the time of skin incision;Motor block status;Duration of motor block;

Secondary

MeasureTime frame
Vital signs;Incidence of adverse reactions;Postoperative neurological complications;

Countries

China

Contacts

Public ContactQingshan Ye;Ruoxi Rao

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