AnxietyPhase 4NCT05925283
Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation
A Phase 4 study testing Midazolam, Esketamine and midazolam and esketamine in people with Anxiety, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Children are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Midazolam, Esketamine and midazolam and esketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2023to 30 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- with American Society of Anesthesiologists (ASA) physical status I or II；
- aged 2-6 years；
- children with weight for age within the normal range
- were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes.
Who cannot join
- Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
- contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either esketamine or midazolam;
- with any nasal pathology,organ dysfunction;
- recently respiratory infection, mental disorder;
- other reasons that researchers hold it is not appropriate to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
Children are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. There are many ways to relieve pediatric anxiety, including preoperative medication, games, and cartoons. Preoperative medication is the most commonly used method to relieve pediatric anxiety.The most commonly used pediatric preoperative sedation drugs are midazolam and esketamine.However, oral midazolam may not produce a sedative effect in 20-40% of patients. A good preoperative anxiety-reducing effect was seen in only 60-80% of cases.Therefore, this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone. This will provide a reference for the selection of safe, reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care.
Read the detailed description
A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called oral midazolam
oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.
EsketamineDrug
Also called Intranasal esketamine
intranasal esketamine 1mg/kg approximately 30-40 mins before surgery using a computer-generated random number table.
midazolam and esketamineDrug
Also called combination with intranasal esketamine and oral midazolam
oral midazolam 0.3mg/kg and intranasal esketamine 0.6mg/kg approximately 30-40 mins before surgery using a computer-generated random number table.
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Placebo comparator | Patients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. Receives: Drug: Midazolam |
| esketamine | Experimental | Patients were assigned to receive intranasal esketamine 1mg/kg approximately 30-40 minutes before surgery using a computer-generated random number table. Receives: Drug: Esketamine |
| midazolam and esketamine | Experimental | Patients were assigned to receive intranasal esketamine 0.6mg/kg and oral midazolam 0.3mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. Receives: Drug: midazolam and esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of cooperation during inhalation anesthesia induction
Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction
Measured: During inhalation anesthesia induction
Secondary outcomes (6)
Anxiety before induction of anesthesia
The Modified Yale Preoperative Anxiety Scale:
The 22-item measure has five behavioural categories: activity, emotional expressivity, alertness and arousal, vocalizations, and interaction with parents. Total scores range from 23.33 through 100 with higher scores indicating greater anxiety.
Measured: Each 10 minutes during the forty minutes of preoperative period
The level of sedation
University of Michigan Sedation Scale:
0 -Awake/Alert
1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.
2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.
3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.
4 - Unarousable.
higher scores mean a higher levels of sedation.
Measured: Each 10 minutes during the forty minutes of preoperative period
Parental separation anxiety scale
A four-point parental separation anxiety scale as follows:
- -Easy separation,
- -Whimpers, but is easily reassured, not clinging,
- - Cries and cannot be easily reassured, but not clinging to parents,
- - Crying and clinging to parents.
The scores of 1 and 2 signified acceptable separation whereas scores of 3 and 4 were classified as difficult separation.
Measured: During the preoperative period
Recovery times
The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete≥9
Measured: Within up to 30 minutes after child's first eye opening in the postoperative period
Pediatric anesthesia emergence delirium
The pediatric anesthesia emergence delirium scale consists of four 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
Number of children with adverse effects
- Bradycardia and/or hypotension need for hemodynamic support
- Desaturation is defined as Oxygen desaturation <90%
- Salivation
- 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 posted29 Jun 2023
- Study start30 Jun 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 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 UniversityXulin Zhang, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925283
- Sponsor's protocol ID
- SAHoWMU-CR2023-03-105
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 29 Jun 2023
- 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 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation
- ClinicalTrials.gov ID
- NCT05925283
- Acronym / sponsor ID
- SAHoWMU-CR2023-03-105
- Conditions
- Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 29 Jun 2023 (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.
Children are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. There are many ways to relieve pediatric anxiety, including preoperative medication, games, and cartoons. Preoperative medication is the most commonly used method to relieve pediatric anxiety.The most commonly used pediatric preoperative sedation drugs are midazolam and esketamine.However, oral midazolam may not produce a sedative effect in 20-40% of patients. A good preoperative anxiety-reducing effect was seen in only 60-80% of cases.Therefore, this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone. This will provide a reference for the selection of safe, reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care.
Detailed description
A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| midazolam | Placebo comparator | Drug: MidazolamPatients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. |
| esketamine | Experimental | Drug: EsketaminePatients were assigned to receive intranasal esketamine 1mg/kg approximately 30-40 minutes before surgery using a computer-generated random number table. |
| midazolam and esketamine | Experimental | Drug: midazolam and esketaminePatients were assigned to receive intranasal esketamine 0.6mg/kg and oral midazolam 0.3mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- with American Society of Anesthesiologists (ASA) physical status I or II；
- aged 2-6 years；
- children with weight for age within the normal range
- were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes.
Key exclusion criteria (5 listed)
- Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
- contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either esketamine or midazolam;
- with any nasal pathology,organ dysfunction;
- recently respiratory infection, mental disorder;
- other reasons that researchers hold it is not appropriate to participate in this trial.
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 |
|---|---|---|
| MidazolamAlso: oral midazolamoral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. | Drug | midazolam |
| EsketamineAlso: Intranasal esketamineintranasal esketamine 1mg/kg approximately 30-40 mins before surgery using a computer-generated random number table. | Drug | esketamine |
| midazolam and esketamineAlso: combination with intranasal esketamine and oral midazolamoral midazolam 0.3mg/kg and intranasal esketamine 0.6mg/kg approximately 30-40 mins before surgery using a computer-generated random number table. | Drug | midazolam and esketamine |
Primary outcome
The degree of cooperation during inhalation anesthesia induction
Time frame: During inhalation anesthesia induction
Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction
6 secondary outcomes
Anxiety before induction of anesthesia
Time frame: Each 10 minutes during the forty minutes of preoperative period
The level of sedation
Time frame: Each 10 minutes during the forty minutes of preoperative period
Parental separation anxiety scale
Time frame: During the preoperative period
Recovery times
Time frame: Within up to 30 minutes after child's first eye opening in the postoperative period
Pediatric anesthesia emergence delirium
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- 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. This study is not recruiting at the moment.
Huacheng Liu principal investigator
Second Affiliated Hospital of Wenzhou Medical University
Xulin Zhang principal investigator
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam, Esketamine and midazolam and esketamine in people with Anxiety, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
The degree of cooperation during inhalation anesthesia induction (time frame: During inhalation anesthesia induction). 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 29 Jun 2023.