Emergence DeliriumPhase 4NCT04621305
Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia
A Phase 4 study testing normal saline, Bolus Remimazolam and Continuous Infusion Remimazolam in people with Emergence Delirium, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- normal saline, Bolus Remimazolam and Continuous Infusion Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2020to Nov 2021
- 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 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 1-6 years；
- -children with weight for age within the normal range；
- -were scheduled laparoscopic surgery by sevoflurane anesthesia.
Who cannot join
- -children who had Abnormal liver and kidney function,Cardiovascular or endocrine dysfunction;
- -allergy or hypersensitive reaction to remimazolam;
- -with any 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
Huacheng Liu, 13957770577, huachengliu@163.com
Yuhang Cai, 18815091585, 838097626@qq.com
About this study
Official title: Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia: a Double-blinded Randomized Clinical Trial
Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The use of sevoflurane has been identified as one of the most important risk factors. In the investigators' study，the researchers conducted the current study to investigate whether remimazolam can reduce incidence of ED.
Read the detailed description
One hundred twenty children aged 1-6 years old were randomly allocated into three equal groups. Anesthesia is induced with propofol，fentanyl and rocuronium. In group P (Placebo group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. In group B (Bolus group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered. In group C (continuous infusion group), anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. Maintain BIS values in the range of 40-60. Recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
- Conditions
- Emergence Delirium
- Being tested
- normal saline, Bolus Remimazolam, Continuous Infusion Remimazolam
- Keywords
- remimazolam, emergence delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineOther
Also called Placebo group
Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered
Bolus RemimazolamDrug
Also called Bolus group
Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered.
Continuous Infusion RemimazolamDrug
Also called Continuous infusion group
Anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered.
| Study group | Role | What they receive |
|---|---|---|
| group P (Placebo group) | Placebo comparator | Patients were assigned to group P (Placebo group) using a computer-generated random number table Receives: Other: normal saline |
| group B (Bolus group) | Experimental | Patients were assigned to group B (Bolus group) using a computer-generated random number table Receives: Drug: Bolus Remimazolam |
| group C (continuous infusion group) | Experimental | Patients were assigned to group C (continuous infusion group) using a computer-generated random number table Receives: Drug: Continuous Infusion Remimazolam |
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)
End tidal sevoflurane concentration
End tidal sevoflurane concentration at BIS 40-60
Measured: During the preoperative 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.
Measured: Within up to 30 minutes after operation
FLACC scale
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
Ramsay Sedation Scale score
- - The patient is anxious and agitated, restless, or both;
- - The patient is cooperative, oriented, and tranquil;
- - The patient responds to commands only;
- - The patient is asleep and shows a brisk response to a light glabellar tap or loud auditory stimulus;
- - The patient is asleep and shows a slow response to a light glabellar tap or loud auditory stimulus;
- - The patient is asleep and shows no response to a light glabellar tap or loud auditory stimulus.
The degree of sedation increased directly with the total score.
Measured: Within up to 30 minutes after operation
Recovery times
The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete≥9
Measured: Up to 30 minutes after operation
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% 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 posted9 Nov 2020
- Study start21 Nov 2020
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT04621305
- Sponsor's protocol ID
- SAHoWMU-CR2020-03-113
- Status last verified
- Jan 2021
- First submitted
- 3 Nov 2020
- Last updated
- 13 Jan 2021
- Results posted
- 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 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia: a Double-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04621305
- Acronym / sponsor ID
- SAHoWMU-CR2020-03-113
- Conditions
- Emergence Delirium
- Keywords
- remimazolam, emergence delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 21 Nov 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 9 Nov 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.
Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The use of sevoflurane has been identified as one of the most important risk factors. In the investigators' study，the researchers conducted the current study to investigate whether remimazolam can reduce incidence of ED.
Detailed description
One hundred twenty children aged 1-6 years old were randomly allocated into three equal groups. Anesthesia is induced with propofol，fentanyl and rocuronium. In group P (Placebo group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. In group B (Bolus group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered. In group C (continuous infusion group), anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. Maintain BIS values in the range of 40-60. Recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group P (Placebo group) | Placebo comparator | Other: normal salinePatients were assigned to group P (Placebo group) using a computer-generated random number table |
| group B (Bolus group) | Experimental | Drug: Bolus RemimazolamPatients were assigned to group B (Bolus group) using a computer-generated random number table |
| group C (continuous infusion group) | Experimental | Drug: Continuous Infusion RemimazolamPatients were assigned to group C (continuous infusion group) using a computer-generated random number table |
Who may qualify
- Ages
- 1 year 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 1-6 years；
- -children with weight for age within the normal range；
- -were scheduled laparoscopic surgery by sevoflurane anesthesia.
Key exclusion criteria (5 listed)
- -children who had Abnormal liver and kidney function,Cardiovascular or endocrine dysfunction;
- -allergy or hypersensitive reaction to remimazolam;
- -with any 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 |
|---|---|---|
| normal salineAlso: Placebo groupAnesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered | Other | group P (Placebo group) |
| Bolus RemimazolamAlso: Bolus groupAnesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered. | Drug | group B (Bolus group) |
| Continuous Infusion RemimazolamAlso: Continuous infusion groupAnesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. | Drug | group C (continuous infusion group) |
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
End tidal sevoflurane concentration
Time frame: During the preoperative period
Pediatric anesthesia emergence delirium
Time frame: Within up to 30 minutes after operation
FLACC scale
Time frame: Within up to 30 minutes after operation
Ramsay Sedation Scale score
Time frame: Within up to 30 minutes after operation
Recovery times
Time frame: Up to 30 minutes 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 13 Jan 2021.
- 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 normal saline, Bolus Remimazolam and Continuous Infusion Remimazolam 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 13 Jan 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 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 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?
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 13 Jan 2021.