NCT06896721

Effects of Nasal Administration of Dexmedetomidine on Pre-anesthesia Sedation, Intraoperative Brain Electrical Activity, and Incidence of Agitation During Recovery in Children

Effects of Nasal Administration of Dexmedetomidine on Pre-Anesthesia Sedation, Intraoperative Brain Electrical Activity, and Incidence of Agitation During Recovery in Children: a Multicenter, Large Sample, Double-Blind, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 627 (estimated)
• Sponsor: Fuzhou Hua · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Accepted

Summary

Pre - operative anxiety and emergence agitation are common issues among pediatric patients, which have various influences on the recovery progress and prognosis of children. Nasal administration of dexmedetomidine is a convenient and non - invasive sedation technique for children. This technique can reduce the incidences of pre - operative anxiety and emergence agitation. However, there are few studies on the effect of dexmedetomidine on intraoperative electroencephalographic activities. In view of this, the investigators elaborately designed a prospective, multi - center, large - sample - sized, double - blind, randomized - controlled clinical trial. This trial aims to provide a basis for drug selection in pediatric anesthesia, ensuring the safety and comfort of pediatric anesthesia. The investigators plan to select 627 participants who will undergo minor surgeries under general anesthesia. Thirty minutes before the surgery, dexmedetomidine or normal saline will be administered nasally to these participants. Before the surgery, the anxiety degree and sedation score of the participants will be assessed; during the surgery, the cooperation degree of patients during anesthesia induction will be evaluated and electroencephalographic monitoring will be carried out; after the surgery, the incidence of emergence agitation, the recovery time and the analgesic score of the participants will be assessed. Throughout the whole process, the occurrence of adverse reactions of participants will be fully monitored, and the adverse reactions will be timely recorded and treated.

Conditions

• Preoperative Anxiety
• Emergence Agitation

Interventions

Type	Name	Description
DRUG	Preoperative sedation with dexmedetomidine was administered nasal before surgery	Do not drink or fast before operation. Before entering the operating room, 2 sprits of dexmedetomidine were administered intranasally (1-2ug/kg) with conventional open venous access
DRUG	Preoperative sedation with normal saline was administered nasal before surgery	Do not drink or fast before operation. Before entering the operating room, 2 sprits of normal saline were administered intranasally (equal volume) with conventional open venous access

Timeline

• Start date: 2025-03-20
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2025-03-26
• Last updated: 2025-03-26