AnxietyPhase 4NCT04135014
Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients
A Phase 4 study testing Midazolam, Dexmedetomidine and Midazolam and Dexmedetomidine in people with Anxiety, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Children tend to anxiety and even fear before survey. And this kind of anxiety will not result in the forced induction of anesthesia, but also may increase the incidence of postoperative agitation in children, even lead to postoperative behavior changes.Currently,Oral midazolam or intranasal dexmedetomidine alone is… 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, Dexmedetomidine and Midazolam and Dexmedetomidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2019to Oct 2020
- 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 dexmedetomidine 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 and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
Official title: Intranasal Dexmedetomidine or Oral Midazolam Alone Versus Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Minor Surgery
Children tend to anxiety and even fear before survey. And this kind of anxiety will not result in the forced induction of anesthesia, but also may increase the incidence of postoperative agitation in children, even lead to postoperative behavior changes.Currently,Oral midazolam or intranasal dexmedetomidine alone is commonly used as a preoperative regimen, but the clinical effects of each single-use are not satisfactory. In the investigators' study，the researchers conducted the current study to investigate whether dexmedetomidine combined with midazolam can increase the rate of satisfactory anesthesia induction in pediatric patients and achieve better sedative effect.
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.
- Conditions
- Anxiety
- Being tested
- Midazolam, Dexmedetomidine, Midazolam and Dexmedetomidine
- Medical subject headings
- Anxiety Disorders
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.
DexmedetomidineDrug
Also called intranasal dexmedetomidine
intranasal dexmedetomidine 2µg.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table.
Midazolam and DexmedetomidineDrug
Also called combination with intranasal dexmedetomidine and oral midazolam
oral midazolam 0.5mg.kg-1 and intranasal dexmedetomidine 1ug.kg-1 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 |
| Dexmedetomidine | Experimental | Patients were assigned to receive intranasal dexmedetomidine 2ug/kg approximately 30-40 minutes before surgery using a computer-generated random number table. Receives: Drug: Dexmedetomidine |
| Midazolam and Dexmedetomidine | Experimental | Patients were assigned to receive intranasal dexmedetomidine 1ug.kg-1 and oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. Receives: Drug: Midazolam and Dexmedetomidine |
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 (7)
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: Before preoperative medication
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 preoperative period
The onset time of satisfactory sedation
The onset time of satisfactory sedation, defined as the time from drug administration to the time when the University of Michigan Sedation Scale reached two points.
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: During the 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 posted22 Oct 2019
- Study start25 Oct 2019
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 138 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 UniversityYuhang Cai, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135014
- Sponsor's protocol ID
- SAHoWMU-CR2019-03-111
- Status last verified
- Nov 2019
- First submitted
- 17 Oct 2019
- Last updated
- 5 Nov 2019
- 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 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine or Oral Midazolam Alone Versus Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Minor Surgery
- ClinicalTrials.gov ID
- NCT04135014
- Acronym / sponsor ID
- SAHoWMU-CR2019-03-111
- Conditions
- Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 22 Oct 2019 (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 tend to anxiety and even fear before survey. And this kind of anxiety will not result in the forced induction of anesthesia, but also may increase the incidence of postoperative agitation in children, even lead to postoperative behavior changes.Currently,Oral midazolam or intranasal dexmedetomidine alone is commonly used as a preoperative regimen, but the clinical effects of each single-use are not satisfactory. In the investigators' study，the researchers conducted the current study to investigate whether dexmedetomidine combined with midazolam can increase the rate of satisfactory anesthesia induction in pediatric patients and achieve better sedative effect.
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
- Single blind (investigator)
- 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. |
| Dexmedetomidine | Experimental | Drug: DexmedetomidinePatients were assigned to receive intranasal dexmedetomidine 2ug/kg approximately 30-40 minutes before surgery using a computer-generated random number table. |
| Midazolam and Dexmedetomidine | Experimental | Drug: Midazolam and DexmedetomidinePatients were assigned to receive intranasal dexmedetomidine 1ug.kg-1 and oral midazolam 0.5mg.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 dexmedetomidine 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 |
| DexmedetomidineAlso: intranasal dexmedetomidineintranasal dexmedetomidine 2µg.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table. | Drug | Dexmedetomidine |
| Midazolam and DexmedetomidineAlso: combination with intranasal dexmedetomidine and oral midazolamoral midazolam 0.5mg.kg-1 and intranasal dexmedetomidine 1ug.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table. | Drug | Midazolam and Dexmedetomidine |
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
7 secondary outcomes
Anxiety before induction of anesthesia
Time frame: Before preoperative medication
The level of sedation
Time frame: Each 10 minutes during the preoperative period
The onset time of satisfactory sedation
Time frame: During the 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 5 Nov 2019.
- 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
Yuhang Cai 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, Dexmedetomidine and Midazolam and Dexmedetomidine 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 5 Nov 2019. 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 5 Nov 2019.