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Alfentanil combined with dexmedetomidine for sedation and analgesia during dressing changes in patients with burns: a prospective, double-blind, randomized controlled study

Alfentanil combined with dexmedetomidine for sedation and analgesia during dressing changes in patients with burns: a prospective, double-blind, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103263
Enrollment
Unknown
Registered
2025-05-27
Start date
2024-10-18
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Burn

Interventions

Experimental group:Dexmedetomidine 0.5ug/kg intravenously pumped for 10min + alfentanil 60ug/kg/h continuous pumping administration
Control group:Normal saline intravenously pumped for 10min + alfentanil 60ug/kg/h continuous pumping administration

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Burn patients preparing for burn dressing changes. 2.Patients aged 18-65 years; 3.The burn site of the patient is not limited, the burn depth is ?-? degree, the burn area is between 1-50%. 4.ASA classification I- III. 5.BMI 18.5 ~ 27.9 kg/m^2. 6.Patient or client signs informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of mental illness or impaired consciousness who are unable to cooperate. 2.Patients with severe organ dysfunction (e.g., cardiovascular and cerebrovascular accidents within 3 months, malignant tumors; current severe hepatic and renal insufficiency). 3.Patients with extensive burns with severe infection and shock; and patients with inhalation lung injury undergoing tracheotomy and mechanical ventilation. 4.Patients who are unconscious and have impaired communication. 5.ASA grade IV or patients who cannot survive for more than 24 hours after treatment. 6.Patients who refuse to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Maximum pain VAS score during burn dressing change;

Secondary

MeasureTime frame
Visual analogue scoring;Whether to use oxygen, airway intervention;Verbal Rating Scale;Whether other medications are used for intervention;Total amount of alfentanil application, times and doses of intraoperative alfentanil addition;Blood concentrations of alfentanil;Ramsay Sedation Score (RSS);Patient satisfaction;Vital signs, conscious state, respiratory depression, nausea and vomiting of patients during and after dressing change;

Countries

China

Contacts

Public ContactZhuang Lei

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

zl11211@rjh.com.cn+86 13918846596

Outcome results

None listed

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