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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Success rate of preoperative sedation [Срок оценки: 30 minutes before medication on the day of surgery]
• Incidence of emergence agitation [Срок оценки: 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 [Срок оценки: 5 minutes after the end of anesthesia induction until the patient is sent out of the operating room,approximately 45 minutes to 2 hours.]

Вторичные конечные точки (6)

• Preoperative anxiety [Срок оценки: Before,15 minutes and 30 minutes after administration]
• Degree of cooperation in anesthesia induction [Срок оценки: After entering the operation room to before anesthesia induction,approximately 3 minutes.]
• Postoperative recovery time [Срок оценки: 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 [Срок оценки: 30 minutes after surgery.]
• Postoperative analgesia score [Срок оценки: 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.]
• Incidence of adverse reactions [Срок оценки: Between the time the patient is sent out of the recovery room after preoperative administration, approximately 2 to 3 hours..]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06896721 · 2024-EEG-Dexmedetomidine

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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