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Effect of Perioperative Intranasal Dexmedetomidine in Adult Oral and Maxillofacial Surgery: A Single-center Randomized Controlled Study

Effect of Perioperative Intranasal Dexmedetomidine in Adult Oral and Maxillofacial Surgery: A Single-center Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129248
Enrollment
Unknown
Registered
2026-08-01
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Postoperative nausea and vomiting

Interventions

Experimental group:Intranasal administration of 100 µg dexmedetomidine using a dedicated nasal spray device 30 minutes before anesthesia induction
Control group:Intranasal administration of equal dose of ph ysiological saline using a dedicated nasal spray device 30 minutes before anesthesia induction

Sponsors

Hospital of Stomatology, SunYat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.ASA physical status I–III; 2.Body mass index (BMI) between 18 and 30 kg/m^² (inclusive); 3.Scheduled to undergo grade II–III oral and maxillofacial jaw surgery under general anesthesia with endotracheal intubation; 4.Estimated operation time < 2 hours and estimated blood loss < 500 mL; 5.Willing to participate in the study and provide written informed consent; 6. Age between 18 and 65 years old (including 18 and 65)

Exclusion criteria

Exclusion criteria: 1.Patients with severe cardiovascular disease, including: sick sinus syndrome; resting heart rate 3 times the upper limit of normal (ULN); serum creatinine > 1.5 times the upper limit of normal (ULN); or estimated glomerular filtration rate (eGFR) 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg; 4.Use of opioid analgesics, antiemetics, or glucocorticoids within 24 hours before surgery; or long-term use of opioids, benzodiazepines, a2-adrenergic receptor agonists/antagonists, or anticholinergic drugs within 7 days before surgery; 5.Cognitive impairment, history of psychiatric disorders, or history of alcohol or substance abuse, resulting in inability to cooperate with scale assessments and study procedures; 6.Known allergy or contraindication to any drug used in this study (e.g., dexmedetomidine, propofol, opioids, etc.); 7.Patients judged by the investigator to be unsuitable for intranasal drug administration (e.g., severe rhinitis, nasal structural abnormalities, nasopharyngeal carcinoma, recurrent epistaxis, or other nasal abnormalities); 8.Participation in another interventional clinical trial within the past 3 months;

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery;

Secondary

MeasureTime frame
Quality of recovery;HRV;Sleep quality within 24 hours after surgery;Use of rescue antiemetic medication and analgesics;Postoperative sedation score;Severity of postoperative nausea and vomiting and number of vomiting episodes;Postoperative pain intensity at 1, 6, and 24 hours;Time to first PONV;Intraoperative opioid consumption;

Countries

China

Contacts

Public ContactYanling Chen

Hospital of Stomatology, SunYat-sen University

chenylman@163.com+86 20 83871483

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026