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Efficacy and Safety of Dexmedetomidine Nasal Spray for Perioperative Anxiety in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Triple-Blind, Multicenter Clinical Study

Efficacy and Safety of Dexmedetomidine Nasal Spray for Perioperative Anxiety in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Triple-Blind, Multicenter Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129660
Enrollment
Unknown
Registered
2026-08-07
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Patients with preoperative anxiety prior to gallbladder stone surgery

Interventions

Experimental Group:Administer dexmedetomidine hydrochloride nasal spray
control group:Give an equal volume of normal saline.

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and voluntarily sign the informed consent form; 2.Patients undergoing elective laparoscopic cholecystectomy under general anesthesia, with an expected surgical duration of =7;

Exclusion criteria

Exclusion criteria: 1.Subjects deemed unsuitable for intranasal administration (e.g., those with severe rhinitis or nasal deformities); 2.Subjects with a history of myocardial infarction or unstable angina; subjects with sick sinus syndrome or severe bradycardia (HR < 30%); 3.Subjects with a history of ischemic stroke or transient ischemic attack; 4.Subjects with poorly controlled blood pressure despite medication; 5.Subjects with a history of psychiatric disorders, cognitive impairment, or epilepsy; 6.Patients with sleep apnea syndrome or a history of airway obstruction; 7.Patients with a history of major surgery, such as cardiac or great vessel surgery, or major organ transplantation (thoracic or abdominal); 8.Subjects with a history of drug abuse, substance abuse, or alcoholism; 9.Patients on long-term sedatives or analgesics; those who have used adrenergic receptor agonists or antagonists prior to randomization; 10.Subjects with coagulation disorders, thyroid dysfunction, or abnormal baseline test results; 11.Subjects with allergies to the drug’s active ingredients or components; 12.Pregnant or breastfeeding women; subjects planning to become pregnant within the specified timeframe and not using contraception; 13.Subjects who have participated in other drug clinical trials (and received investigational drugs) within the past 6 months; 14.Other circumstances deemed by the investigator to make the subject unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Preoperative Anxiety Score;

Secondary

MeasureTime frame
Pain Score;Peroperative Sleep Quality Score;Restore Quality Score Check;Incidence of Adverse Reactions;

Countries

China

Contacts

Public ContactHu Haijie

West China Hospital of Sichuan University

hhj1063557621@163.com+86 85 85424562

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026