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Effect of Dexmedetomidine Combined with Dexamethasone on Perioperative Itching Induced by Fentanyl Spinal Anesthesia in Lower Limb Fracture Surgery

Effect of Dexmedetomidine Combined with Dexamethasone on Perioperative Itching Induced by Fentanyl Spinal Anesthesia in Lower Limb Fracture Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117348
Enrollment
Unknown
Registered
2026-01-22
Start date
2026-01-26
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Perioperative pruritus

Interventions

Dexmedetomidine group (Group D):After an intravenous injection of 5 ml normal saline, a loading dose of dexmedetomidine (0.5 µg/kg) was infused via pump over 10 minutes. Following the completion of th
Dexmedetomidine combined with dexamethasone group (Group DM):Dexamethasone at a dose of 0.1 mg/kg was diluted in 5 ml of normal saline for intravenous injection, followed by pump infusion of a loading

Sponsors

Ningxia Hui Autonomous Region People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18-70 years undergoing lower limb fracture surgery. (2) Patients with ASA physical status classification I-III. (3) Patients receiving spinal anesthesia with fentanyl combined with bupivacaine. (4)The study protocol was approved by the Ethics Committee, and written informed consent was obtained from all participants.

Exclusion criteria

Exclusion criteria: (1) The patient declined to participate in this trial; (2) Patients with diabetes mellitus or pruritic conditions; (3) Patients with spinal deformities or local infection at the puncture site; (4) Patients with coagulation disorders, or hepatic, renal, cardiac, or pulmonary insufficiency; (5) Patients with tolerance, allergy, or a history of adverse reactions to the investigational drugs; (6) Patients with a history of dementia or psychiatric disorders, or current use of sedatives or antidepressants; (7) Patients with severe visual or hearing impairment; (8) Patients deemed ineligible for this study by the attending physician or investigator for other reasons, which must be documented; (9) Patients concurrently participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
pruritus;

Secondary

MeasureTime frame
Intraoperative vital signs;Intraoperative core body temperature;Ramsay Sedation Scale scores from intraoperative period to 24 hours after surgery;VAS analgesic scores from intraoperative period to 24 hours after surgery;Adverse reactions from intraoperative period to 24 hours after surgery;Quality of Recovery-15 (QoR-15) scores at 24 hours after surgery;Duration of sensory and motor block of the lower extremities after surgery;

Countries

China

Contacts

Public ContactWenxun Liu

Ningxia Hui Autonomous Region People's Hospital

38361345@qq.com+86 189 0959 7279

Outcome results

None listed

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