Emergence AgitationNCT05527314
Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
A study testing Remimazolam, Sevoflurane and Fentanyl in people with Emergence Agitation and Remimazolam, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly… Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Emergence Agitation, Remimazolam, Sevoflurane
- What is being tested?
- Remimazolam, Sevoflurane and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2022to 7 Feb 2023
- Phase
- Interventional
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA Ⅰ-Ⅱ
- Aged 3-8 years, weight > 10 kg, sex was not limited；
- Children were scheduled for selective ophthalmic surgery under general anesthesia,
Who cannot join
- Respiratory infection was present within 4 weeks before surgery.
- Potential or presence of difficult airways, airway obstruction, sleep apnea, and other contraindications to general anesthesia.
- The blood routine or blood biochemical indexes were obviously abnormal.
- Allergy or hypersensitive reaction to test drug, including remimazolam, sevoflurane, and remifentanil.
- Any child who has taken benzodiazepines in the last 3 months.
- Unable to cooperate to complete the test, and the guardian refused to attend.
- 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
the Second Affiliated Hospital of Nanchang University, Nanchang University
Nanchang, Jiangxi
About this study
Official title: Effect of Total Intravenous Anesthesia With Remimazolam vs Sevoflurane Inhalation Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether Remimazolam reduces the incidence of emergence agitation in children after ophthalmic surgery, compared to sevoflurane (RCT).
- Conditions
- Emergence Agitation, Remimazolam, Sevoflurane, Pediatric Ophthalmic Surgery, Anesthesia, General
- Being tested
- Remimazolam, Sevoflurane, Fentanyl, Cisatracurium Besylate, Remifentanil
- Keywords
- Anesthesia, General, Pediatric ophthalmic surgery, Emergence Agitation, 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
Anesthesia was induced with Remimazolam 0.4-0.8 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h until the end of surgery.
SevofluraneDrug
Anesthesia was induced with 8 % Sevoflorane by sevoflurane volatilization tank until the loss of consciousness (LoC), followed by 2 %-3 % Sevoflorane until the end of surgery.
FentanylDrug
Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.
Cisatracurium BesylateDrug
Anesthesia was induced with cisatracurium besilate 0.1 mg/kg by intravenous injection after the LoC. And the cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate during the operation.
RemifentanilDrug
After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | 1. Induction of anesthesia Slowly inject Remimazolam 0.4-0.8 mg/kg (about 1 minute) until loss of consciousness (LoC), if the degree of sedation is insufficient, additional Remimazolam (0.05 mg/kg each time) is allowed. After the LoC, fentanyl 3-4 ug/kg and cisatracurium besilate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.
2. Maintenance of anesthesia Remimazolam 1~2 mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 20 %. Receives: Drug: Remimazolam; Drug: Fentanyl; Drug: Cisatracurium Besylate; Drug: Remifentanil |
| Sevoflorane | Active comparator | 1. Induction of anesthesia After the sevoflurane volatilization tank is adjusted to 8 % and the fresh gas flow rate is 5 L/min, the suitable mask connects with the outlet of the loop and covers the nose of the child. After the LoC, the sevoflurane volatilization tank is set to 3 % and the fresh gas flow rate is 2 L/min to maintain autonomous respiration. At the same time, fentanyl 3-4 ug/kg and cisatracurium besilate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.
2. Maintenance of anesthesia Continuous inhalation of sevoflurane concentration 2 %-3 % and remifentanil 0.1-0.3 ug/kg/min intravenous pump to maintain sedation and assistant analgesia, and cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 20 %. Receives: Drug: Sevoflurane; Drug: Fentanyl; Drug: Cisatracurium Besylate; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence agitation
The PAED 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. PAED scale >12 at any time indicates presence of emergence agitation.
Measured: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
The incidence of emergence agitation
The Watcha scale consists of four items and scores >2 at any time indicates presence of emergence agitation.
Measured: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
The incidence of emergence agitation
The 5-point scale consists of five items. The scores ≥4 and lasts for more than 5 minutes indicate presence of emergence agitation.
Measured: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
Secondary outcomes (8)
Systolic pressure
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Measured: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Diastolic pressure
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Measured: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Mean pressure
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Measured: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Heart rate
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Measured: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Recovery times
The period from discontinuation of anesthetic drugs to the recovery of the child's self-consciousness and can respond correctly to external stimuli.
Measured: Up to 30 minutes after operation
Delayed emergence
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
Measured: Up to 30 minutes after operation
Postoperative Pain
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: During the recovery from anesthesia.
Complication
All the perioperative complications are recorded.
Measured: During the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start23 Aug 2022
- Primary completion6 Feb 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a RCTs.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuzhou Hua, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527314
- Sponsor's protocol ID
- 2022-EA-1
- Status last verified
- Mar 2023
- First submitted
- 29 Aug 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Intravenous Anesthesia With Remimazolam vs Sevoflurane Inhalation Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
- ClinicalTrials.gov ID
- NCT05527314
- Acronym / sponsor ID
- 2022-EA-1
- Conditions
- Emergence Agitation, Remimazolam, Sevoflurane, Pediatric Ophthalmic Surgery, Anesthesia, General
- Keywords
- Anesthesia, General, Pediatric ophthalmic surgery, Emergence Agitation, Remimazolam, Sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 2 Sep 2022 (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.
As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether Remimazolam reduces the incidence of emergence agitation in children after ophthalmic surgery, compared to sevoflurane (RCT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a RCTs.
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam, Drug: Fentanyl, Drug: Cisatracurium Besylate, Drug: Remifentanil1. Induction of anesthesia Slowly inject Remimazolam 0.4-0.8 mg/kg (about 1 minute) until loss of consciousness (LoC), if the degree of sedation is insufficient, additional Remimazolam (0.05 mg/kg each time) is allowed. After the LoC, fentanyl 3-4 ug/kg and cisatracurium besilate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. 2. Maintenance of anesthesia Remimazolam 1~2 mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 20 %. |
| Sevoflorane | Active comparator | Drug: Sevoflurane, Drug: Fentanyl, Drug: Cisatracurium Besylate, Drug: Remifentanil1. Induction of anesthesia After the sevoflurane volatilization tank is adjusted to 8 % and the fresh gas flow rate is 5 L/min, the suitable mask connects with the outlet of the loop and covers the nose of the child. After the LoC, the sevoflurane volatilization tank is set to 3 % and the fresh gas flow rate is 2 L/min to maintain autonomous respiration. At the same time, fentanyl 3-4 ug/kg and cisatracurium besilate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. 2. Maintenance of anesthesia Continuous inhalation of sevoflurane concentration 2 %-3 % and remifentanil 0.1-0.3 ug/kg/min intravenous pump to maintain sedation and assistant analgesia, and cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 20 %. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA Ⅰ-Ⅱ
- Aged 3-8 years, weight > 10 kg, sex was not limited；
- Children were scheduled for selective ophthalmic surgery under general anesthesia,
Key exclusion criteria (7 listed)
- Respiratory infection was present within 4 weeks before surgery.
- Potential or presence of difficult airways, airway obstruction, sleep apnea, and other contraindications to general anesthesia.
- The blood routine or blood biochemical indexes were obviously abnormal.
- Allergy or hypersensitive reaction to test drug, including remimazolam, sevoflurane, and remifentanil.
- Any child who has taken benzodiazepines in the last 3 months.
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 |
|---|---|---|
| RemimazolamAnesthesia was induced with Remimazolam 0.4-0.8 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h until the end of surgery. | Drug | Remimazolam |
| SevofluraneAnesthesia was induced with 8 % Sevoflorane by sevoflurane volatilization tank until the loss of consciousness (LoC), followed by 2 %-3 % Sevoflorane until the end of surgery. | Drug | Sevoflorane |
| FentanylAnesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC. | Drug | Remimazolam, Sevoflorane |
| Cisatracurium BesylateAnesthesia was induced with cisatracurium besilate 0.1 mg/kg by intravenous injection after the LoC. And the cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate during the operation. | Drug | Remimazolam, Sevoflorane |
| RemifentanilAfter the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery. | Drug | Remimazolam, Sevoflorane |
Primary outcome
The incidence of emergence agitation
Time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
The PAED 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. PAED scale >12 at any time indicates presence of emergence agitation.
The incidence of emergence agitation
Time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
The Watcha scale consists of four items and scores >2 at any time indicates presence of emergence agitation.
The incidence of emergence agitation
Time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
The 5-point scale consists of five items. The scores ≥4 and lasts for more than 5 minutes indicate presence of emergence agitation.
8 secondary outcomes
Systolic pressure
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Diastolic pressure
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Mean pressure
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Heart rate
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Recovery times
Time frame: Up to 30 minutes after operation
Delayed emergence
Time frame: Up to 30 minutes after operation
Postoperative Pain
Time frame: During the recovery from anesthesia.
Complication
Time frame: During the perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam, Sevoflurane and Fentanyl in people with Emergence Agitation and Remimazolam, run by Second Affiliated Hospital of Nanchang 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 24 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of emergence agitation (time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes). The study lists 3 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 24 Mar 2023.