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The effect of dexmedetomidine hydrochloride nasal spray on the success rate of spinal anesthesia and patient satisfaction in patients undergoing knee and hip joint replacement surgery: A prospective, randomized, controlled trial

The effect of dexmedetomidine hydrochloride nasal spray on the success rate of spinal anesthesia and patient satisfaction in patients undergoing knee and hip joint replacement surgery: A prospective, randomized, controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114414
Enrollment
Unknown
Registered
2025-12-11
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

None

Interventions

The nasal spray of dexmedetomidine hydrochloride group:Before the first use, it is necessary to pre-spray 7 times to activate the nasal spray pump. Spray into the nasal cavity, each side of the nostri
Saline nasal spray group:Before the first use, it is necessary to pre-spray 7 times to activate the nasal spray pump. Spray into the nasal cavity, each side of the nostril should receive 1 spray, stay

Sponsors

Qingdao Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) ASA I-III grade; (2) Age range: 50 - 80 years old; (3) Gender: Open to both males and females; (4) BMI: 18.5 - 29 kg/m^2; (5) Patients scheduled to undergo knee and hip joint replacement surgery at Qingdao Municipal Hospital on an elective basis.

Exclusion criteria

Exclusion criteria: (1) Patients with poor compliance and inability to cooperate with the surgery; (2) Patients with severe organic diseases (coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities) (3) Second-degree or higher atrioventricular conduction block, bradycardia (HR < 50 beats per minute), hypotension (SBP < 90 mmHg); (4) History of neurological diseases; chronic pain history; drug addiction and alcohol abuse; long-term use of opioid drugs history; (5) Patients allergic to the nasal spray of dexmedetomidine hydrochloride or its components; (6) Low educational level, unable to complete the survey of the relevant scoring scale; (7) History of nasal surgery, severe rhinitis, or abnormal nasal structure (such as deviation of the nasal septum); (8) Participated in other drug clinical trials within the past 4 weeks; (9) Infection at the puncture site, history of lumbar surgery, severe spinal injury, coagulation dysfunction or congenital developmental abnormalities (such as scoliosis), and other conditions not suitable for spinal anesthesia or contraindications to spinal anesthesia.

Design outcomes

Primary

MeasureTime frame
The success rate of the first spinal anesthesia puncture;Satisfaction score during spinal anesthesia process;

Secondary

MeasureTime frame
Ramsay score after using the nasal spray;The hemodynamic changes after using the nasal spray;The incidence of adverse events during the surgery;VAS pain score;Number of needle insertions, number of direction changes;Operation duration;

Countries

China

Contacts

Public ContactXu Lin

Qingdao Municipal Hospital

linxu_green@126.com+86 186 7895 1375

Outcome results

None listed

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