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Safety and reliability of dexmedetomidine nasal spray for programmed sedation and analgesia during infusion port implantation in adults

Safety and reliability of dexmedetomidine nasal spray for programmed sedation and analgesia during infusion port implantation in adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093619
Enrollment
Unknown
Registered
2024-12-09
Start date
2024-12-09
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

None listed

Interventions

Dextrome sedation group:Dexmedetomidine nasal drops of 100µg (50ug per nostril) were given before operation, and surgical treatment was performed after the drug took effect.
Control group:The same amount of normal saline was given before surgery.

Sponsors

Zhongshan Hospital(Xiamen), Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age: 18-80 years old. ASA grade I - III. Patients undergoing implantation at infusion port under nerve block. Voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: Patient rejection. nasopharyngeal infection or tumor. Patients allergic to the experimental drug. Existing or recent medical conditions that may affect the absorption, distribution, metabolism, excretion, or response to the investigational drug. History of heart disease (valvular insufficiency, severe left ventricular dysfunction), abnormal pacemaker or ECG rhythm (bradycardia <50/min, second or third degree atrioventricular block). Long-term use of opioids or use of other analgesic adjuvants. Participated in other clinical trials within a month. Patients with pregnancy, lactation, and liver and kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
Patient's post-operative Iowa Anesthesia Satisfaction Scale (ISAS);

Secondary

MeasureTime frame
Postoperative VAS scores of patients;Postoperative sleep quality (St. Mary's Hospital Sleep Questionnaire);Associated adverse reactions in patients after administration;Patient's perioperative vital signs;

Countries

China

Contacts

Public ContactJie Tong

Zhongshan Hospital(Xiamen), Fudan University

tong.jie@zsxmhospital.com+86 182 0590 2856

Outcome results

None listed

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