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Clinical Observation of Dexmedetomidine Nasal Spray in Palliative Sedation for Terminal Patients: A Randomized, Parallel Study

Clinical Observation of Dexmedetomidine Nasal Spray in Palliative Sedation for Terminal Patients: A Randomized, Parallel Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110418
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-10-13
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

None

Interventions

Group B:In Group B, the RASS-PAL sedation score was evaluated at an interval of 20 minutes. If it did not reach 0 or below, an additional spray of 25µg dexmed
Group A:In Group A, the RASS-PAL sedation score was evaluated at an interval of 10 minutes. If it did not reach 0 or below, an additional spray of 25µg dexmed
Group C:In Group C, the RASS-PAL sedation score was evaluated at an interval of 30 minutes. If it did not reach 0 or below, an additional spray of 25µg dexmed

Sponsors

Zhejiang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.The age should be no less than 18 years old; 2.The patient must be diagnosed by an oncologist or a doctor trained in palliative care as being in the terminal stage of a malignant tumor; 3.Terminal patients who have received systematic palliative care and are willing to receive palliative sedation treatment; 4.Do not perform invasive cardiopulmonary resuscitation surgeries, such as tracheal intubation, cardiac compression or ventilator-assisted ventilation;

Exclusion criteria

Exclusion criteria: 1.Researchers consider subjects who are not suitable for nasal spray administration (such as those with severe rhinitis, nasal deformities, nasogastric feeding patients, etc.); 2.Patients for whom detailed sedation and vital signs cannot be obtained; 3.Selective a 2-adrenergic receptor agonists (clonidine) or antagonists (such as phenbenzamine, etc.) were used within 7 days prior to randomization. 4.Patients with a history of heart failure who have undergone inpatient or outpatient examinations in the past 12 months and those with known severe left ventricular dysfunction (defined as a known echocardiographic left ventricular ejection fraction <20%); 5.Subjects with unclear consciousness and mental system disorders; 6.Allergic to dexmedetomidine; 7.Patients who are currently participating in or planning to participate in any interventional clinical trials; 8.The researchers believe that there are any other reasons that make the patient unsuitable to participate in this study;

Design outcomes

Primary

MeasureTime frame
Duration of sedation;Success rate of sedation;

Secondary

MeasureTime frame
32/5000 Incidence of adverse events (hypotension, bradycardia, arrhythmia, sinus arrest, hypertension, etc.);Pain score and dosage of analgesic drugs;

Countries

China

Contacts

Public ContactYanfei Xia

Zhejiang Hospital

xiayf0303@126.com+86 571 8159 5068

Outcome results

None listed

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