Emergence DeliriumPhase 4CEDCRSANCT06214117
Comparison of Emergence Delirium: Remimazolam vs Sevoflurane Anesthesia
A Phase 4 study testing Remimazolam and Sevoflurane in people with Emergence Delirium, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. Pediatric ear, nose, and throat (ENT) surgery is one of the most common surgical types for postoperative delirium in children. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Remimazolam and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Feb 2024to Mar 2025
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-6 years;
- American Society of Anaesthesiologist (ASA) I or II;
- Booked for Tonsillectomy and Adenoidectomy;
- BMI for age between the 25th and 85th percentiles according to the 2000 Centers for Disease Control and Prevention (CDC) growth charts.
Who cannot join
- Children (ASA III- IV) who had abnormal liver and kidney function, cardiovascular, endocrine dysfunction, or any other organ dysfunction;
- Allergy or hypersensitive reaction to remimazolam;
- mental disorder
- Recently respiratory infection;
- Other reasons that researchers hold it is not appropriate to participate in this trial: under specialized care or lived in social welfare institutions, or any other factors that could affect their ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
Official title: Comparison of Emergence Agitation in Children Following Tonsillectomy and Adenoidectomy Under Remimazolam or Sevoflurane General Anesthesia
Emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. Pediatric ear, nose, and throat (ENT) surgery is one of the most common surgical types for postoperative delirium in children. Sevoflurane anesthesia is also a known cause of postoperative delirium. Therefore, this study aims to explore whether there is a difference in the incidence of postoperative delirium in children under remimazolam general anesthesia and sevoflurane anesthesia.
Read the detailed description
children aged 3-6 years old were randomly and equally allocated into two groups: Group R remimazolam, Group S with sevoflurane, respectively.
- Conditions
- Emergence Delirium
- Being tested
- Remimazolam, Sevoflurane
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called intravenous anesthesia
Anesthesia induction:intravenous Fentanyl 2-3 μg/kg, remimazolam 0.3-0.5 mg/kg and Rocuronium 0.6mg/kg; Maintenance of anesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h), and remifentanil will administer at an initial infusion rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min).
SevofluraneDrug
Also called inhalation anesthesia
Anesthesia induction: Anesthesia will induce with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min, and then intravenous fentanyl (2-3 μg/kg) and rocuronium (0.6 mg/kg); Maintenance of anaesthesia: Anesthesia depth will maintain at 1-1.5 minimum alveolar concentration (MAC), and remifentanil was infuse at an initial rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min).
| Study group | Role | What they receive |
|---|---|---|
| Group R | Experimental | Induction of anesthesia:Anesthesia will induced with remimazolam at 0.3-0.5 mg/kg; Maintenance of anaesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h). Receives: Drug: Remimazolam |
| Group S | Placebo comparator | Induction of anesthesia:Anesthesia will induced with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min; Maintenance of anaesthesia:Anesthesia depth was maintained at 1-1.5 MAC by sevoflurane. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of 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 ≥10 at any time indicates presence of emergence delirium.
Measured: Within up to 30 minutes after operation
Secondary outcomes (6)
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.
Measured: Within up to 30 minutes after operation
The Face, Legs, Activity, Cry, Consolability Scale (FLACC)
The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10.
The degree of pain increased directly with the total score.
Measured: Within up to 30 minutes after operation
Extubation time
The time from discontinuation of anesthesia drug to extubation.
Measured: Within up to 30 minutes after operation
Recovery times
The time from discontinuation of anesthesia drug to the first open eye of the children and to achieve aldrete≥9
Measured: Within up to 30 minutes after operation
PHBQ-AS
Post-Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) is a parental report measure used to assess negative behavior change after hospitalization, consisting of 11 items on 1-5 score. The PHBQ-AS score will be calculated for each respondent as the mean score of all individual items answered on the questionnaire.
A score above 3 will indicate the presence of negative behavioral change, a score equal to 3 will indicate no behavioral change, and a score below 3 will indicate an improvement in behavior.
Measured: 3 days after operation
Number of children with adverse effects
Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Any adverse effects requiring interventions
Measured: Up to 24 hours including 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 posted19 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huacheng Liu, Ph.D., Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214117
- Sponsor's protocol ID
- SAHoWMU-CR2024-03-103
- Acronym
- CEDCRSA
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma HY, Cai YH, Zhong JW, Chen J, Wang Z, Lin CY, Wang QQ, Liu HC. The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial. Front Pharmacol. 2024 Jun 25;15:1373006. doi: 10.3389/fphar.2024.1373006. eCollection 2024.
PubMed 38983921
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Emergence Agitation in Children Following Tonsillectomy and Adenoidectomy Under Remimazolam or Sevoflurane General Anesthesia
- ClinicalTrials.gov ID
- NCT06214117
- Acronym / sponsor ID
- CEDCRSA / SAHoWMU-CR2024-03-103
- Conditions
- Emergence Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 19 Jan 2024 (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.
Emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. Pediatric ear, nose, and throat (ENT) surgery is one of the most common surgical types for postoperative delirium in children. Sevoflurane anesthesia is also a known cause of postoperative delirium. Therefore, this study aims to explore whether there is a difference in the incidence of postoperative delirium in children under remimazolam general anesthesia and sevoflurane anesthesia.
Detailed description
children aged 3-6 years old were randomly and equally allocated into two groups: Group R remimazolam, Group S with sevoflurane, respectively.
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 |
|---|---|---|
| Group R | Experimental | Drug: RemimazolamInduction of anesthesia:Anesthesia will induced with remimazolam at 0.3-0.5 mg/kg; Maintenance of anaesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h). |
| Group S | Placebo comparator | Drug: SevofluraneInduction of anesthesia:Anesthesia will induced with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min; Maintenance of anaesthesia:Anesthesia depth was maintained at 1-1.5 MAC by sevoflurane. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 3-6 years;
- American Society of Anaesthesiologist (ASA) I or II;
- Booked for Tonsillectomy and Adenoidectomy;
- BMI for age between the 25th and 85th percentiles according to the 2000 Centers for Disease Control and Prevention (CDC) growth charts.
Key exclusion criteria (5 listed)
- Children (ASA III- IV) who had abnormal liver and kidney function, cardiovascular, endocrine dysfunction, or any other organ dysfunction;
- Allergy or hypersensitive reaction to remimazolam;
- mental disorder
- Recently respiratory infection;
- Other reasons that researchers hold it is not appropriate to participate in this trial: under specialized care or lived in social welfare institutions, or any other factors that could affect their ability to participate in the study.
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 |
|---|---|---|
| RemimazolamAlso: intravenous anesthesiaAnesthesia induction:intravenous Fentanyl 2-3 μg/kg, remimazolam 0.3-0.5 mg/kg and Rocuronium 0.6mg/kg; Maintenance of anesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h), and remifentanil will administer at an initial infusion rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min). | Drug | Group R |
| SevofluraneAlso: inhalation anesthesiaAnesthesia induction: Anesthesia will induce with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min, and then intravenous fentanyl (2-3 μg/kg) and rocuronium (0.6 mg/kg); Maintenance of anaesthesia: Anesthesia depth will maintain at 1-1.5 minimum alveolar concentration (MAC), and remifentanil was infuse at an initial rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min). | Drug | Group S |
Primary outcome
The incidence of emergence delirium
Time frame: Within up to 30 minutes after operation
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 ≥10 at any time indicates presence of emergence delirium.
6 secondary outcomes
Pediatric anesthesia emergence delirium
Time frame: Within up to 30 minutes after operation
The Face, Legs, Activity, Cry, Consolability Scale (FLACC)
Time frame: Within up to 30 minutes after operation
Extubation time
Time frame: Within up to 30 minutes after operation
Recovery times
Time frame: Within up to 30 minutes after operation
PHBQ-AS
Time frame: 3 days after operation
Number of children with adverse effects
Time frame: Up to 24 hours including 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 19 Jan 2024.
- Derived from this study: PubMed 38983921Ma HY, Cai YH, Zhong JW, Chen J, Wang Z, Lin CY, Wang QQ, Liu HC. The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial. Front Pharmacol. 2024 Jun 25;15:1373006. doi: 10.3389/fphar.2024.1373006. eCollection 2024.
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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, Ph.D. 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 Remimazolam and Sevoflurane in people with Emergence Delirium, 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 19 Jan 2024. 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, Ph.D. (13957770577 ext. +86, huachengliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of emergence delirium (time frame: Within up to 30 minutes after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06214117, which also lists 1 linked publication.
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 19 Jan 2024.