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

Overview

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.

Interventions

• 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

Primary outcome measures

• Success rate of preoperative sedation [Time frame: 30 minutes before medication on the day of surgery]
• Incidence of emergence agitation [Time frame: 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 [Time frame: 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 outcome measures (6)

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06896721 · 2024-EEG-Dexmedetomidine

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗