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

NCT06896721 | Not Yet Recruiting Phase 4

• 1 other identifier: 2024-EEG-Dexmedetomidine
• Study Type: interventional
• Target: 627
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preoperative Anxiety; Emergence Agitation

Outcome Measures

Primary Outcomes (3)

• Success rate of preoperative sedation

  Successful sedation was considered when participants received Ramsay sedation score ≥3 on the sedation scale 30 minutes after medication.

  30 minutes before medication on the day of surgery

• Incidence of emergence agitation

  Immediately after extubation, the Pediatric Anesthesia Emergence Delirium (PAED) Scale and the 5-Point Agitation Scale for Emergence Agitation were used to assess the level of postoperative emergence agitation (EA) in the participants. Subsequent assessments were conducted every 15 minutes until the participants was transferred back to the ward. A PAED score ≥ 12 or a 5-Point Agitation Scale score \> 3 could be diagnosed as emergence agitation.

  After extubation, patients were evaluated every 15 minutes until they were sent out of the recovery room, approximately 15 minutes to 1 hour.

• Intraoperative brain electrical activity differences

  The characteristics of four kinds of brain wave α, β ,δ and θ were analyzed by professional EEG analysis software

  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 (6)

• Preoperative anxiety

  Before,15 minutes and 30 minutes after administration

• Degree of cooperation in anesthesia induction

  After entering the operation room to before anesthesia induction,approximately 3 minutes.

• Postoperative recovery time

  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.

• Incidence of delayed recovery

  30 minutes after surgery.

• Postoperative analgesia score

  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.

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Drug: Preoperative sedation with dexmedetomidine was administered nasal before surgery

Placebo

PLACEBO COMPARATOR

Drug: Preoperative sedation with normal saline was administered nasal before surgery

Interventions

Preoperative sedation with dexmedetomidine was administered nasal before surgery DRUG

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

Dexmedetomidine

Preoperative sedation with normal saline was administered nasal before surgery DRUG

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

Placebo

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ≤ 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuzhou Hua: lead

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Fuzhou Hua

CONTACT

86-15170238929; huafuzhou@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: March 26, 2025
• Study Start: March 20, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share