Preoperative AnxietyPhase 4NCT06896721
Effects of Nasal Administration of Dexmedetomidine on Pre-anesthesia Sedation, Intraoperative Brain Electrical Activity, and Incidence of Agitation During Recovery in Children
A Phase 4 study testing Preoperative sedation with dexmedetomidine was administered nasal before surgery and Preoperative sedation with normal saline was administered nasal before surgery in people with Preoperative Anxiety and Emergence Agitation, run by Fuzhou Hua.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Emergence Agitation
- What is being tested?
- Preoperative sedation with dexmedetomidine was administered nasal before surgery and Preoperative sedation with normal saline was administered nasal before surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 627 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2025to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Preoperative sedation with dexmedetomidine was administered nasal before surgery, Preoperative sedation with normal saline was administered nasal before surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative sedation with dexmedetomidine was administered nasal before surgeryDrug
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
Preoperative sedation with normal saline was administered nasal before surgeryDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Preoperative sedation with dexmedetomidine was administered nasal before surgery |
| Placebo | Placebo comparator | Not described Receives: Drug: Preoperative sedation with normal saline was administered nasal before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of preoperative sedation
Successful sedation was considered when participants received Ramsay sedation score ≥3 on the sedation scale 30 minutes after medication.
Measured: 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.
Measured: 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
Measured: 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
The modified Yale Preoperative Anxiety Scale (mYPAS) was used to quantify the anxiety level of children before and 15min and 30min after administration, respectively. There are 22 items in the scale, including activity, language, emotional expression, arousal state and dependence on parents, etc. According to the difference of each item, children's behavior is divided into grades 1~4 or 1~6, and the total score after conversion is 23.33~100 points (conversion formula: The actual score of each part = (score ÷ number of items in each part) × (100÷ number of parts)), the higher the total score, the higher the anxiety level of the child.
Measured: Before,15 minutes and 30 minutes after administration
Degree of cooperation in anesthesia induction
The Induction Compliance Checklist (ICC) was used to assess the child's cooperation during the anesthesia induction period after entering the operating room and before the induction of anesthesia. The checklist includes 10 negative behaviors, totaling 11 items, covering all possible reactions of the child during anesthesia induction. A score of 0 is recorded if the child exhibits no negative behaviors during induction, while a score of 1 is recorded for each negative behavior observed. The scores for each item are summed, with a maximum score of 10. A lower ICC score indicates better cooperation during the induction period. A score of 0 indicates full cooperation, 1-3 indicates moderate cooperation, and a score ≥ 4 indicates non-cooperation.
Measured: After entering the operation room to before anesthesia induction,approximately 3 minutes.
Postoperative recovery time
The period from the cessation of anesthetic administration until the patient regains consciousness and can respond appropriately to external stimuli.
Measured: 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
Participants fail to open their eyes, shake hands, or show any significant response to painful stimuli for more than 30 minutes after surgery.
Measured: 30 minutes after surgery.
Postoperative analgesia score
Immediately after postoperative awakening, the FLACC (Face, Legs, Activity, Cry, Consolability) Pain Assessment Scale was used to evaluate the participant's pain intensity. The total score ranges from 0 to 10, with a higher score indicating a greater level of pain experienced by the participant.
Measured: 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
Measured: Between the time the patient is sent out of the recovery room after preoperative administration, approximately 2 to 3 hours..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 627 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou Hua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fuzhou Hua, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896721
- Sponsor's protocol ID
- 2024-EEG-Dexmedetomidine
- Status last verified
- Mar 2025
- First submitted
- 19 Jan 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06896721
- Acronym / sponsor ID
- 2024-EEG-Dexmedetomidine
- Conditions
- Preoperative Anxiety, Emergence Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 627 participants (estimated)
- Lead sponsor
- Fuzhou HuaUniversity, hospital or other
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 2≤ age ≤6 years old, gender is not limited;
Key exclusion criteria (6 listed)
- Respiratory tract infection occurs within 4 weeks before surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative sedation with dexmedetomidine was administered nasal before surgeryDo 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 | Dexmedetomidine |
| Preoperative sedation with normal saline was administered nasal before surgeryDo 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 | Drug | Placebo |
Primary outcome
Success rate of preoperative sedation
Time frame: 30 minutes before medication on the day of surgery
Successful sedation was considered when participants received Ramsay sedation score ≥3 on the sedation scale 30 minutes after medication.
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.
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.
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.
The characteristics of four kinds of brain wave α, β ,δ and θ were analyzed by professional EEG analysis software
6 secondary outcomes
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..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preoperative sedation with dexmedetomidine was administered nasal before surgery and Preoperative sedation with normal saline was administered nasal before surgery in people with Preoperative Anxiety and Emergence Agitation, run by Fuzhou Hua.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuzhou Hua (86-15170238929, huafuzhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of preoperative sedation (time frame: 30 minutes before medication on the day of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.