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Efficacy and safety of dexmedetomidine nasal spray for preoperative sedation in adults with perioperative anxiety -- A multicenter, randomized, double-blind, practical clinical study

Efficacy and safety of dexmedetomidine nasal spray for preoperative sedation in adults with perioperative anxiety -- A multicenter, randomized, double-blind, practical clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102079
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Preoperative anxiety, preoperative anxiety can lead to preoperative and intraoperative hypertension, rapid heart rate and other conditions, which can seriously affect surgical treatment

Interventions

Control group:Saline spray
Experimental group:Dexmedetomidine hydrochloride nasal spray was administered

Sponsors

People's Hospital of Leshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged >= 18 years who underwent elective surgery were of all genders; 2. The ASA score is I-III; 3. 18.5 kg/m2 <= BMI<28kg/m^2; 4. Preoperative screening of patients with anxiety; 5. Volunteer to participate in the study and sign an informed consent;

Exclusion criteria

Exclusion criteria: 1. History and risk of airway difficulties (e.g., subjects with obstructive sleep apnea syndrome); 2. The subjects had psychiatric disorders (such as schizophrenia, mania, insanity, etc.), subjects taking anti-anxiety drugs before surgery (such as benzodiazepines, melatonin, pregabalin, etc.), arrhythmias (sinus tachycardia, sinus bradycardia, ventricular premature beat, etc.), and cognitive disorders; 3. Subjects with a history of myocardial infarction or unstable angina pectoris, or a history of cardiac insufficiency within 6 months prior to the screening period; 4. Subjects with poor blood pressure control after medication (hypertension: systolic >= 180mmHg, or diastolic >= 110mmHg, or hypotension: systolic < 90mmHg or diastolic <= 50mmHg); 5. Allergic or contraindicated to dexmedetomidine hydrochloride and its drug components; 6. Subjects are not suitable for nasal administration (such as severe rhinitis, nasal deformity, etc.) or do not want to receive nasal administration; 7. Other conditions considered inappropriate for the study;

Design outcomes

Primary

MeasureTime frame
Incidence of first hypertension after entry and before anesthesia;Incidence of anxiety before anesthesia began in patients after entry;

Secondary

MeasureTime frame
Quality of recovery scores at day 1, day 3, and day 30 (QoR-15);The incidence of preoperative anxiety in different surgical types;Postoperative pain score, incidence of anxiety, sleep score, nausea and vomiting, length of hospital stay, medical costs, and mortality;

Countries

China

Contacts

Public ContactLiang Jin

People's Hospital of Leshan

xzmzjl2828@163.com+86 833 211 9359

Outcome results

None listed

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