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The appropriate dosage of Dexmedetomidine Hydrochloride Nasal Spray for sedation and amnesia during the puncture of intrathecal anesthesia in orthopedic lower limb surgery

The appropriate dosage of Dexmedetomidine Hydrochloride Nasal Spray for sedation and amnesia during the puncture of intrathecal anesthesia in orthopedic lower limb surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600115975
Enrollment
Unknown
Registered
2026-01-04
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Orthopedic lower limb surgery

Interventions

Group D1:30 minutes before the start of the spinal anesthesia puncture, the patient was given a nasal spray of dexmedetomidine hydrochloride 25 µg.
Group D2:30 minutes before the start of the spinal anesthesia puncture, the patient was given a nasal spray of dexmedetomidine hydrochloride 50 µg.
Group NS:30 minutes before the start of spinal anesthesia puncture, the patient was given a nasal spray of 0.125 ml 0.9% sodium chloride solution.

Sponsors

Lu'an City Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form; 2. Patients scheduled for elective orthopedic lower limb surgery at this hospital; 3. Aged 18-65 years; 4. ASA classification (American Society of Anesthesiologists physical status) of I or II.

Exclusion criteria

Exclusion criteria: 1. History of long-term or recent use of antipsychotic, sedative, or analgesic drugs; 2. Severe heart, lung, liver, or kidney dysfunction (ASA grade III or above); 3. History of lumbar spine disorders and low back pain; 4. Abnormal coagulation function; 5. Currently participating in another clinical trial.

Design outcomes

Primary

MeasureTime frame
Assess the patient's degree of forgetfulness regarding the intrathecal anesthesia puncture procedure;

Secondary

MeasureTime frame
Sleep Quality Score: Richards-Campbell Sleep Questionnaire before surgery and three days after surgery;Incidence and severity of postoperative nausea and vomiting (PONV);Postoperative complications;Assess the patient's pain using the Visual Analog Scale (VAS, 0-10 points).;Days of hospitalization;Hospitalization expenses;

Countries

China

Contacts

Public ContactChen Jianxiang

Lu'an City Traditional Chinese Medicine Hospital

mzcjx1999@163.com+86 173 5291 5264

Outcome results

None listed

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