Perioperative AnxietyPhase 4NCT04273035
Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety
A Phase 4 study testing Midazolam oral solution and IPAD in people with Perioperative Anxiety and Preanesthetic Medication, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Perioperative Anxiety, Preanesthetic Medication, Inhalation Anesthesia
- What is being tested?
- Midazolam oral solution and IPAD
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2020to 28 Feb 2022
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 1 year and <8 years old
- ASA class 1 or 2 (American Society of Anesthesiologists Physical Status Classification System)
- Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
- Written informed consent by the legal parents or caretaker
Who cannot join
- Parents of the patient wish not to participate with the study
- Parents are not able to give informed consent (language barrier, legally incapable)
- A contraindication for the use of premedication with midazolam
- A known allergy to midazolam
- A contraindication for premedication in general
- A contraindication for the use of a gas-induction/gas-anesthesia
Show all 14Show fewer
- A contraindication for the use of sevoflurane
- A known mental retardation of the child
- Preoperative behavioral disturbances and psychiatric disorders
- Any use of psychoactive medication
- A known photosensitive epilepsy
- A previous operation within 3 months of the time of scheduled operation
- Any other contraindication for the use of the study medication
- Previous history of multiple surgery (>3)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel (UZ Brussel)
Jette, 1090
Alex Van Hoorn, MD, +324749232, Alex.VanHoorn@uzbrussel.be
Pangiotis Flamée, MD, +324773143, Panagiotis.Flamee@uzbrussel.be
About this study
Official title: The Effect of Handheld-multimedia Versus Oral Midazolam Preanesthetic on the Level of Perioperative Anxiety in Pediatric Day-care Surgery: A Randomized Controlled Trial
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. Secondly to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia.
Read the detailed description
Perioperative anxiety in children is a common multifactorial influenced and triggered entity with an incidence as high as 50%. Especially (mask)induction of anesthesia is considered one of the most stressful experiences for a child undergoing surgery. A common practice worldwide to diminish the level of anxiety prior to anesthesia is premedication with the benzodiazepine midazolam in order to improve cooperation during induction.
Premedication with midazolam has a primary purpose to reduce preoperative anxiety and has inherent to a benzodiazepine its sedative effects. Although these effects are implied, negative effects of premedication: respiratory complications, paradoxical negative behavior has been reported. Although alternative medications have been studied, studies for non-pharmacological anxiety-reduction remain limited.
Non-pharmacological anxiety-reduction by distraction including Tablet or IPAD-multimedia might be a readily available alternative for midazolam premedication. Potentially limiting the use of psychoactive agents, limiting the need for preoperative sedation and therefore possibly decrease secondary respiratory complications in pediatric surgical day-care.
Objective:
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the mask-induction of anesthesia. Secondly to evaluate the need for midazolam premedication in pediatric day-care surgery patients induced by inhalational anesthesia.
- Conditions
- Perioperative Anxiety, Preanesthetic Medication, Inhalation Anesthesia, Ambulatory Surgery, Tonsillectomy, Circumcision
- Being tested
- Midazolam oral solution, IPAD
- Keywords
- Preanesthetic medication, Handheld computer, Midazolam, Multimedia, Anxiety, Mask induction, Day Care Surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam oral solutionDrug
Also called Buccolam
Oral Buccolam
IPADDevice
Also called Handheld multimedia, tablet
Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Midazolam Group | Active comparator | * Midazolam(Buccolam 5mg/ml)
* 0.5mg/kg oral, max 12mg
* one time
* given 30 min prior to going to holding Receives: Drug: Midazolam oral solution |
| IPAD group | Active comparator | * No premedication
* IPAD when arriving at the holding
* any games, movies, clips, puzzles Receives: Device: IPAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level at induction
Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 * 100 and therefore a score between 23,3-100 Scored prior moment of mask induction (T2)
Measured: Directly prior to induction of anesthesia, 20 minutes
Anesthesiologist Satisfaction Induction
Satisfactory Score for Induction/Anesthesia: 5 point scale: Very satisfactory, Satisfactory, Neutral, Unsatisfactory and Very satisfactory Scored in the OR directly post induction
Measured: During induction of anesthesia 10 minutes
Secondary outcomes (26)
Anxiety level at Daycare
Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 * 100 and therefore a score between 23,3-100 Scored at Daycare (T0) when leaving to holding
Measured: Leaving daycare, 10 minutes
Anxiety level at holding
Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 * 100 and therefore a score between 23,3-100 Scored at holding (T1) 10 minutes after arrival
Measured: On holding, 20 minutes
Anxiety level at recovery
Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 * 100 and therefore a score between 23,3-100 Scored at recovery (T3) 15 minutes after awake
Measured: 15 minutes after awake, 30 minutes
Anxiety level Change Daycare vs OR
Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/4 * 100 and therefore a score between 23,3-100
Measured: change during daycare (T0) and induction(T2) in the OR, average 1 hour
Sedation level at Daycare
Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at Daycare (T0) when leaving to holding
Measured: 10 minutes
Sedation level at holding
Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored (T1) 10 minutes after arrival holding
Measured: 20 minutes
Sedation level at induction
Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at moment of mask induction (T2)
Measured: 10 minutes
Sedation level at recovery
Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored 15 minutes after arrival recovery (T3)
Measured: 30 minutes
Laryngospasm at induction
Laryngospasm by Four-point scale:
- No Laryngospasm
- Mild laryngospasm (relieved by jaw thrust and 100% oxygen),
- Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation)
- Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post-induction
Measured: 10 minutes
Laryngospasm post extubation/post laryngeal mask
Laryngospasm by Four-point scale:
- No Laryngospasm
- Mild laryngospasm (relieved by jaw thrust and 100% oxygen),
- Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation)
- Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post detubation/post laryngeal mask
Measured: 10 minutes
Bronchospasm postinduction
Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR postinduction
Measured: 10 minutes
Bronchospasm post detubation/laryngeal mask
Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR post detonation/laryngeal mask
Measured: 10 minutes
Postoperative Pain
The pain observation scale for young children (POCIS-Score) score 0-7, scoring 0 or1 for • face-expression: frowning/grimaces = 1, sound crying/moan =1, breathing: irregular/gasping/holding=1, body tonus: tense/shiver/restless =1, movement of arms: tense/fist/restless =1, movement of legs: tense/pulled up/flexed = 1, mood: agitation/restless = 1 Scored on the recovery 30 minutes after arrival
Measured: 40 minutes
Parental Satisfaction on the anxiety-management at daycare
- Very satisfied
- Satisfied
- Neutral
- Unsatisfactory
- Very Unsatisfactory Scored at daycare-surgery (T0)
Measured: 10 minutes
Parental Satisfaction on the anxiety-management at holding
- Very satisfied
- Satisfied
- Neutral
- Unsatisfactory
- Very Unsatisfactory Scored at holding (T1)
Measured: 10 minutes
Parental Satisfaction on the anxiety-management at OR
- Very satisfied
- Satisfied
- Neutral
- Unsatisfactory
- Very Unsatisfactory Scored after induction and parent has left the OR (T2)
Measured: 10 minutes
Parental Satisfaction on the anxiety-management at recovery
- Very satisfied
- Satisfied
- Neutral
- Unsatisfactory
- Very Unsatisfactory Scored at the recovery (T3)
Measured: 10 minutes
Parental Stress level at day care
Parental Stress level in 5 - point scale- ´I feel':
- Extremely Stressed
- Very stressed
- moderate stressed
- Low stressed
- Very low stressed scored at day care (T0)
Measured: 10 minutes
Parental Stress level at holding
Parental Stress level in 5 - point scale- ´I feel':
- Extremely Stressed
- Very stressed
- moderate stressed
- Low stressed
- Very low stressed Scored at holding (T1)
Measured: 10 minutes
Parental Stress level at OR
Parental Stress level in 5 - point scale- ´I feel':
- Extremely Stressed
- Very stressed
- moderate stressed
- Low stressed
- Very low stressed Scored at OR (T2)
Measured: 10 minutes
Parental Stress level at recovery
Parental Stress level in 5 - point scale- ´I feel':
- Extremely Stressed
- Very stressed
- moderate stressed
- Low stressed
- Very low stressed Scored at recovery (T3)
Measured: 10 minutes
Overall Parental Satisfaction
5- Point scale
- Very satisfied
- Satisfied
- Neutral
- Unsatisfactory
- Very Unsatisfactory Scored when leaving recovery
Measured: 10 minutes
Child Stress level by parent at daycare
Child Stress level by parent, 5- Point scale
- Happy, plays
- Slightly worried
- Worried, stops playing
- Fears, crying
- Hysterical Scored at daycare-surgery (T0)
Measured: 10 minutes
Child Stress level by parent at holding
Child Stress level by parent, 5- Point scale
- Happy, plays
- Slightly worried
- Worried, stops playing
- Fears, crying
- Hysterical Scored at holding (T1)
Measured: 10 minutes
Child Stress level by parent at OR
Child Stress level by parent, 5- Point scale
- happy, plays
- slightly worried
- worried, stops playing
- fear, crying
- hysterical Scored at OR after induction (T2)
Measured: 10 minutes
Child Stress level by parent at Recovery
Child Stress level by parent, 5- Point scale
- Happy, plays
- Slightly worried
- Worried, stops playing
- Fear, crying
- Hysterical Scored at recovery (T3)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative AnxietyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Model description
- Group A: midazolam premedicated, standard of care Group B: IPAD, no midazolam premedication
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Van Hoorn, MD, Principal investigator, Resident of department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273035
- Sponsor's protocol ID
- 2019/318
- Other IDs
- 2019-004671-39, 2019
- Status last verified
- Apr 2021
- First submitted
- 5 Feb 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * Individual participant data will be available after deidentification * For researchers who provide a methodological proposal * Achieving aims in the proposal * Proposals needs to be directed to the principal investigators
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Handheld-multimedia Versus Oral Midazolam Preanesthetic on the Level of Perioperative Anxiety in Pediatric Day-care Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04273035
- Acronym / sponsor ID
- 2019/318
- Conditions
- Perioperative Anxiety, Preanesthetic Medication, Inhalation Anesthesia, Ambulatory Surgery, Tonsillectomy, Circumcision
- Keywords
- Preanesthetic medication, Handheld computer, Midazolam, Multimedia, Anxiety, Mask induction, Day Care Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 17 Feb 2020 (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.
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. Secondly to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia.
Detailed description
Perioperative anxiety in children is a common multifactorial influenced and triggered entity with an incidence as high as 50%. Especially (mask)induction of anesthesia is considered one of the most stressful experiences for a child undergoing surgery. A common practice worldwide to diminish the level of anxiety prior to anesthesia is premedication with the benzodiazepine midazolam in order to improve cooperation during induction.
Premedication with midazolam has a primary purpose to reduce preoperative anxiety and has inherent to a benzodiazepine its sedative effects. Although these effects are implied, negative effects of premedication: respiratory complications, paradoxical negative behavior has been reported. Although alternative medications have been studied, studies for non-pharmacological anxiety-reduction remain limited.
Non-pharmacological anxiety-reduction by distraction including Tablet or IPAD-multimedia might be a readily available alternative for midazolam premedication. Potentially limiting the use of psychoactive agents, limiting the need for preoperative sedation and therefore possibly decrease secondary respiratory complications in pediatric surgical day-care.
Objective:
The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the mask-induction of anesthesia. Secondly to evaluate the need for midazolam premedication in pediatric day-care surgery patients induced by inhalational anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A: midazolam premedicated, standard of care Group B: IPAD, no midazolam premedication
| Arm | Type | Receives |
|---|---|---|
| Midazolam Group | Active comparator | Drug: Midazolam oral solution* Midazolam(Buccolam 5mg/ml) * 0.5mg/kg oral, max 12mg * one time * given 30 min prior to going to holding |
| IPAD group | Active comparator | Device: IPAD* No premedication * IPAD when arriving at the holding * any games, movies, clips, puzzles |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ≥ 1 year and <8 years old
- ASA class 1 or 2 (American Society of Anesthesiologists Physical Status Classification System)
- Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care
- Written informed consent by the legal parents or caretaker
Key exclusion criteria (14 listed)
- Parents of the patient wish not to participate with the study
- Parents are not able to give informed consent (language barrier, legally incapable)
- A contraindication for the use of premedication with midazolam
- A known allergy to midazolam
- A contraindication for premedication in general
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 |
|---|---|---|
| Midazolam oral solutionAlso: BuccolamOral Buccolam | Drug | Midazolam Group |
| IPADAlso: Handheld multimedia, tabletPlaying any game, film, clip or puzzle on a tablet till after induction of anesthesia | Device | IPAD group |
Primary outcome
Anxiety level at induction
Time frame: Directly prior to induction of anesthesia, 20 minutes
Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 * 100 and therefore a score between 23,3-100 Scored prior moment of mask induction (T2)
Anesthesiologist Satisfaction Induction
Time frame: During induction of anesthesia 10 minutes
Satisfactory Score for Induction/Anesthesia: 5 point scale: Very satisfactory, Satisfactory, Neutral, Unsatisfactory and Very satisfactory Scored in the OR directly post induction
26 secondary outcomes
Anxiety level at Daycare
Time frame: Leaving daycare, 10 minutes
Anxiety level at holding
Time frame: On holding, 20 minutes
Anxiety level at recovery
Time frame: 15 minutes after awake, 30 minutes
Anxiety level Change Daycare vs OR
Time frame: change during daycare (T0) and induction(T2) in the OR, average 1 hour
Sedation level at Daycare
Time frame: 10 minutes
Sedation level at holding
Time frame: 20 minutes
Sedation level at induction
Time frame: 10 minutes
Sedation level at recovery
Time frame: 30 minutes
Laryngospasm at induction
Time frame: 10 minutes
Laryngospasm post extubation/post laryngeal mask
Time frame: 10 minutes
Bronchospasm postinduction
Time frame: 10 minutes
Bronchospasm post detubation/laryngeal mask
Time frame: 10 minutes
Postoperative Pain
Time frame: 40 minutes
Parental Satisfaction on the anxiety-management at daycare
Time frame: 10 minutes
Parental Satisfaction on the anxiety-management at holding
Time frame: 10 minutes
Parental Satisfaction on the anxiety-management at OR
Time frame: 10 minutes
Parental Satisfaction on the anxiety-management at recovery
Time frame: 10 minutes
Parental Stress level at day care
Time frame: 10 minutes
Parental Stress level at holding
Time frame: 10 minutes
Parental Stress level at OR
Time frame: 10 minutes
Parental Stress level at recovery
Time frame: 10 minutes
Overall Parental Satisfaction
Time frame: 10 minutes
Child Stress level by parent at daycare
Time frame: 10 minutes
Child Stress level by parent at holding
Time frame: 10 minutes
Child Stress level by parent at OR
Time frame: 10 minutes
Child Stress level by parent at Recovery
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: Yes. * Individual participant data will be available after deidentification * For researchers who provide a methodological proposal * Achieving aims in the proposal * Proposals needs to be directed to the principal investigators
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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.
Alex Van Hoorn, MD principal investigator
Resident of department of Anesthesiology
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 oral solution and IPAD in people with Perioperative Anxiety and Preanesthetic Medication, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 14 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 4 May 2021. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Van Hoorn, MD (+32468187852, Alex.VanHoorn@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level at induction (time frame: Directly prior to induction of anesthesia, 20 minutes). The study lists 2 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 4 May 2021.