Clinical trial NCT06896721: Effects of Nasal Administration of Dexmedetomidine on Pre-anesthesia Sedation, Intraoperative Brain Electrical Activity, and Incidence of Agitation During Recovery in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Preoperative Anxiety
Emergence Agitation
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 627
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 2≤ age ≤6 years old, gender is not limited;

  * ASA anesthesia grade I \~ II; ③ For children who intend to undergo minor surgery under general anesthesia (including but not limited to minor surgery such as ENT surgery and hernia surgery), the operation duration is expected to be no more than 2 hours; ④ Family members agree to participate in the study and voluntarily sign informed consent;

Exclusion Criteria:

* Respiratory tract infection occurs within 4 weeks before surgery;

  * Potential or other contraindications to general anesthesia;

    * There are nasal diseases, nasal bleeding, sinusitis, nasal polyps and other conditions that affect nasal absorption; ④ Heart, liver, kidney and other vital organ dysfunction or blood system diseases;

      * Allergy or intolerance to dexmedetomidine or other α2-adrenergic receptor agonists;

        * Patients with mental illness or neurological diseases;

          * Unable to complete the test, the child's guardian refused to participate; ⑧ Have participated in other clinical trials or need to participate in other clinical trials during the study period; ⑨ Other reasons that the researchers consider inappropriate to participate in this study.

Primary outcomes:
measure: Success rate of preoperative sedation
timeFrame: 30 minutes before medication on the day of surgery
measure: Incidence of emergence agitation
timeFrame: After extubation, patients were evaluated every 15 minutes until they were sent out of the recovery room, approximately 15 minutes to 1 hour.
measure: Intraoperative brain electrical activity differences
timeFrame: 5 minutes after the end of anesthesia induction until the patient is sent out of the operating room,approximately 45 minutes to 2 hours.
Secondary outcomes:
measure: Preoperative anxiety
timeFrame: Before,15 minutes and 30 minutes after administration
measure: Degree of cooperation in anesthesia induction
timeFrame: After entering the operation room to before anesthesia induction,approximately 3 minutes.
measure: Postoperative recovery time
timeFrame: A period of time beginning after the withdrawal of narcotic drugs until the patient regains self-consciousness and can respond correctly to external stimuli, approximately 15 minutes to 1 hour.
measure: Incidence of delayed recovery
timeFrame: 30 minutes after surgery.
measure: Postoperative analgesia score
timeFrame: Immediately after recovery, the patients were re-evaluated every 15 minutes until they were sent out of the recovery room, approximately 15 minutes to 1 hour.
measure: Incidence of adverse reactions
timeFrame: Between the time the patient is sent out of the recovery room after preoperative administration, approximately 2 to 3 hours..
Other outcomes:
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