Preoperative AnxietyPhase 4NCT06853431
Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
A Phase 4 study testing dexmedetomidine and Esketamine in people with Preoperative Anxiety and Preoperative Sedation, run by Second Affiliated Hospital of Wenzhou Medical University at 2 sites in China.
Trial summary
For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction… Read more about this study
- Who is it for?
- Ages 12 to 72 months
- Conditions the study is for
- Preoperative Anxiety, Preoperative Sedation, Children
- What is being tested?
- dexmedetomidine and Esketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2025to 30 Nov 2025
- 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 12 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status classification Grade I or II;
- Age 1-6 years old;
- Children who need to undergo general anesthesia for elective surgery;
- Weight within the normal range;
- Signed informed consent form. -
Who cannot join
- The child's guardian or the child themselves refuses to participate in the study;
- Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia;
- Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications;
- Individuals with a history of heart, brain, liver, kidney, or metabolic diseases;
- Individuals with an upper respiratory tract infection within the past two weeks;
- Individuals with other diseases that may cause harm to the subject. -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Huacheng Liu, 18957755138, huachengliu@163.com
- Recruiting
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Huacheng Liu, 18957755138, huachengliu@163.com
Chenrui Zhou, 15157910160, zcr934419@163.com
About this study
For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction [6]. This study aims to explore the ED50 and ED95 and clinical effects of the combination of dexmedetomidine and esketamine nasal drops for preoperative sedation in children of different ages undergoing general anesthesia, providing a theoretical basis for the combined use of dexmedetomidine and esketamine for preoperative sedation in children undergoing general anesthesia.
Read the detailed description
Children scheduled for general anesthesia were randomly divided into two groups based on age: Group T consisted of toddlers aged 1 - 3 years old, and Group P consisted of preschool children aged 3 - 6 years old. The initial dose for both groups was dexmedetomidine 1μg/kg and esketamine 0.5mg/kg.
The sedation depth of the children was assessed using the Ramsay Sedation Scale. An unbiased coin - flipping design was adopted: after esketamine 0.5mg/kg was administered intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally. The adjusted dose of dexmedetomidine was 0.25μg/kg. If the sedation of the previous child failed, the intranasal dose of dexmedetomidine for the next child would be increased by 0.25μg/kg. If the sedation of the previous child was successful, a card would be drawn to decide the induction dose for the next patient. A total of 20 cards, which were identical in appearance, were prepared. The probability of administering the same dose was 19/20 (95%), and the probability of reducing the dose for the next patient by 0.25μg/kg was 1/20 (5%).
After drug administration, an anesthesiologist who was unaware of the medication usage would rate the sedation level using the Ramsay Sedation Scale every 5 minutes. The non - invasive blood pressure (NIBP), heart rate (HR), respiratory rate (RR), and blood oxygen saturation (SpO2) were recorded before drug administration (0 minutes, baseline) and at 5, 10, 15, 20, 25, and 30 minutes after drug administration.The onset time was defined as the time from intranasal administration to an RSS score of ≥ 4. Thirty minutes after intranasal administration, an experienced nurse who was unaware of the intranasal drug dose performed intravenous cannulation. The emotional state was assessed using the Emotional State Scale (ESS - 4) during intravenous cannulation. Successful intravenous cannulation was defined as an ESS - 4 score of ≤ 2 during cannulation, regardless of whether the intravenous infusion catheter was successfully inserted.The Pediatric Anesthesia Emergence Delirium (PAED) scale was used to assess the degree of emergence delirium in children. The onset time of sedation (the time to reach an RSS score of ≥4 after intranasal drug administration), surgical time (from the start to the end of the surgery), and awakening time (from the closure of the sevoflurane vaporizer to an Aldrete score of 9 or above) were recorded.
- Conditions
- Preoperative Anxiety, Preoperative Sedation, Children, Dexmedetomidine, Esketamine, ED95
- Being tested
- dexmedetomidine, Esketamine
- Keywords
- Preoperative Anxiety, Preoperative sedation, Children, Dexmedetomidine, Esketamine, ED95, ED50, preoperative sedation of children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
esketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg.
EsketamineDrug
esketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg.
| Study group | Role | What they receive |
|---|---|---|
| 1-3 years old | Experimental | The sedation depth of the children was assessed using the Ramsay Sedation Scale. This study was conducted using the biased coin design up - and - down method. The dose for the subsequent participant was determined based on the response of the previous participant. If the previous participant achieved successful sedation, the next participant had a 95% probability of receiving the same dose of dexmedetomidine as the previous participant and a 5% probability of receiving a lower dose of dexmedetomidine (a dose reduction of 0.25 µg/kg). If the previous participant failed to achieve sedation, the dose of dexmedetomidine for the next participant was increased by 0.25 µg/kg until the number of participants reached 40. Receives: Drug: dexmedetomidine; Drug: Esketamine |
| 3-6 years old | Experimental | The sedation depth of the children was assessed using the Ramsay Sedation Scale. This study was conducted using the biased coin design up - and - down method. The dose for the subsequent participant was determined based on the response of the previous participant. If the previous participant achieved successful sedation, the next participant had a 95% probability of receiving the same dose of dexmedetomidine as the previous participant and a 5% probability of receiving a lower dose of dexmedetomidine (a dose reduction of 0.25 µg/kg). If the previous participant failed to achieve sedation, the dose of dexmedetomidine for the next participant was increased by 0.25 µg/kg until the number of participants reached 40. Receives: Drug: dexmedetomidine; Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of sedation
After drug administration, every 5 minutes, an anesthesiologist who was unaware of the medication used assessed the sedation level using the Ramsay Sedation Scale(RSS).Within 30 minutes after the intranasal medication was administered, the Ramsay Sedation Score (RSS) was ≥4.
Measured: Within 30 minutes after intranasal administration of dexmedetomidine.
Secondary outcomes (4)
Intravenous cannulation success rates
Emotional State Score
- Calm
- Apprehensive, not smiling, tentative behavior, withdrawn
- Crying
- Thrashing, crying with movements of the arms and legs, resisting
Measured: 30 minutes after intranasal administration of dexmedetomidine.
Awakening time
From the closure of the sevoflurane vaporizer to the time when the patient opened their eyes.
Measured: Within 1 hour of entering the Post Anesthesia Care Unit (PACU).
Postoperative agitation
The pediatric anesthesia emergence delirium scale consists of five items. Each item is scored 0-4 yielding a total between 0 and 20.
The degree of emergence delirium increased directly with the total score. pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium.
Measured: Within up to 15-30 minutes after child's first eye opening in the postoperative period
Number of children with adverse effects
１、Bradycardia and/or hypotension need for hemodynamic support; 2、Desaturation is defined as Oxygen desaturation <90%; 3、Nausea and vomiting; 4、Any adverse effects requiring interventions.
Measured: Up to 24 hours including preoperative, intraoperative, and postoperative periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Mar 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (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.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huacheng Liu, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853431
- Sponsor's protocol ID
- SAHoWMU-CR2025-03-105
- Status last verified
- Nov 2025
- First submitted
- 24 Feb 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
- ClinicalTrials.gov ID
- NCT06853431
- Acronym / sponsor ID
- SAHoWMU-CR2025-03-105
- Conditions
- Preoperative Anxiety, Preoperative Sedation, Children, Dexmedetomidine, Esketamine, ED95
- Keywords
- Preoperative Anxiety, Preoperative sedation, Children, Dexmedetomidine, Esketamine, ED95, ED50, preoperative sedation of children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 3 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.
For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction [6]. This study aims to explore the ED50 and ED95 and clinical effects of the combination of dexmedetomidine and esketamine nasal drops for preoperative sedation in children of different ages undergoing general anesthesia, providing a theoretical basis for the combined use of dexmedetomidine and esketamine for preoperative sedation in children undergoing general anesthesia.
Detailed description
Children scheduled for general anesthesia were randomly divided into two groups based on age: Group T consisted of toddlers aged 1 - 3 years old, and Group P consisted of preschool children aged 3 - 6 years old. The initial dose for both groups was dexmedetomidine 1μg/kg and esketamine 0.5mg/kg.
The sedation depth of the children was assessed using the Ramsay Sedation Scale. An unbiased coin - flipping design was adopted: after esketamine 0.5mg/kg was administered intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally. The adjusted dose of dexmedetomidine was 0.25μg/kg. If the sedation of the previous child failed, the intranasal dose of dexmedetomidine for the next child would be increased by 0.25μg/kg. If the sedation of the previous child was successful, a card would be drawn to decide the induction dose for the next patient. A total of 20 cards, which were identical in appearance, were prepared. The probability of administering the same dose was 19/20 (95%), and the probability of reducing the dose for the next patient by 0.25μg/kg was 1/20 (5%).
After drug administration, an anesthesiologist who was unaware of the medication usage would rate the sedation level using the Ramsay Sedation Scale every 5 minutes. The non - invasive blood pressure (NIBP), heart rate (HR), respiratory rate (RR), and blood oxygen saturation (SpO2) were recorded before drug administration (0 minutes, baseline) and at 5, 10, 15, 20, 25, and 30 minutes after drug administration.The onset time was defined as the time from intranasal administration to an RSS score of ≥ 4. Thirty minutes after intranasal administration, an experienced nurse who was unaware of the intranasal drug dose performed intravenous cannulation. The emotional state was assessed using the Emotional State Scale (ESS - 4) during intravenous cannulation. Successful intravenous cannulation was defined as an ESS - 4 score of ≤ 2 during cannulation, regardless of whether the intravenous infusion catheter was successfully inserted.The Pediatric Anesthesia Emergence Delirium (PAED) scale was used to assess the degree of emergence delirium in children. The onset time of sedation (the time to reach an RSS score of ≥4 after intranasal drug administration), surgical time (from the start to the end of the surgery), and awakening time (from the closure of the sevoflurane vaporizer to an Aldrete score of 9 or above) were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-3 years old | Experimental | Drug: dexmedetomidine, Drug: EsketamineThe sedation depth of the children was assessed using the Ramsay Sedation Scale. This study was conducted using the biased coin design up - and - down method. The dose for the subsequent participant was determined based on the response of the previous participant. If the previous participant achieved successful sedation, the next participant had a 95% probability of receiving the same dose of dexmedetomidine as the previous participant and a 5% probability of receiving a lower dose of dexmedetomidine (a dose reduction of 0.25 µg/kg). If the previous participant failed to achieve sedation, the dose of dexmedetomidine for the next participant was increased by 0.25 µg/kg until the number of participants reached 40. |
| 3-6 years old | Experimental | Drug: dexmedetomidine, Drug: EsketamineThe sedation depth of the children was assessed using the Ramsay Sedation Scale. This study was conducted using the biased coin design up - and - down method. The dose for the subsequent participant was determined based on the response of the previous participant. If the previous participant achieved successful sedation, the next participant had a 95% probability of receiving the same dose of dexmedetomidine as the previous participant and a 5% probability of receiving a lower dose of dexmedetomidine (a dose reduction of 0.25 µg/kg). If the previous participant failed to achieve sedation, the dose of dexmedetomidine for the next participant was increased by 0.25 µg/kg until the number of participants reached 40. |
Who may qualify
- Ages
- 12 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ASA physical status classification Grade I or II;
- Age 1-6 years old;
- Children who need to undergo general anesthesia for elective surgery;
- Weight within the normal range;
- Signed informed consent form. -
Key exclusion criteria (6 listed)
- The child's guardian or the child themselves refuses to participate in the study;
- Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia;
- Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications;
- Individuals with a history of heart, brain, liver, kidney, or metabolic diseases;
- Individuals with an upper respiratory tract infection within the past two weeks;
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 |
|---|---|---|
| dexmedetomidineesketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg. | Drug | 1-3 years old, 3-6 years old |
| Esketamineesketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg. | Drug | 1-3 years old, 3-6 years old |
Primary outcome
Onset time of sedation
Time frame: Within 30 minutes after intranasal administration of dexmedetomidine.
After drug administration, every 5 minutes, an anesthesiologist who was unaware of the medication used assessed the sedation level using the Ramsay Sedation Scale(RSS).Within 30 minutes after the intranasal medication was administered, the Ramsay Sedation Score (RSS) was ≥4.
4 secondary outcomes
Intravenous cannulation success rates
Time frame: 30 minutes after intranasal administration of dexmedetomidine.
Awakening time
Time frame: Within 1 hour of entering the Post Anesthesia Care Unit (PACU).
Postoperative agitation
Time frame: Within up to 15-30 minutes after child's first eye opening in the postoperative period
Number of children with adverse effects
Time frame: Up to 24 hours including preoperative, intraoperative, and postoperative periods
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 2 Dec 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.
Huacheng Liu principal investigator
Second Affiliated Hospital of Wenzhou Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine and Esketamine in people with Preoperative Anxiety and Preoperative Sedation, run by Second Affiliated Hospital of Wenzhou Medical University at 2 sites in China.
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 5 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Huacheng Liu (18957755138, huachengliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset time of sedation (time frame: Within 30 minutes after intranasal administration of dexmedetomidine.). 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 2 Dec 2025.