Back to resultsEffect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
Primary Purpose
Emergence Agitation, Remimazolam, Sevoflurane
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remimazolam
Sevoflurane
Fentanyl
Cisatracurium Besylate
Remifentanil
Sponsored by
About this trial
This is an interventional prevention trial for Emergence Agitation focused on measuring Anesthesia, General, Pediatric ophthalmic surgery, Emergence Agitation, Remimazolam, Sevoflurane
Eligibility Criteria
Inclusion Criteria:
- ASA Ⅰ-Ⅱ
- Aged 3-8 years, weight > 10 kg, sex was not limited；
- Children were scheduled for selective ophthalmic surgery under general anesthesia,
Exclusion Criteria:
- 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.
Sites / Locations
- the Second Affiliated Hospital of Nanchang University, Nanchang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remimazolam
Sevoflorane
Arm Description
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. 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 %.
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. 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 %.
Outcomes
Primary Outcome Measures
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.
The incidence of emergence agitation
The Watcha scale consists of four items and scores >2 at any time indicates presence of emergence agitation.
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.
Secondary Outcome Measures
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".
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".
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".
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".
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.
Delayed emergence
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
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.
Complication
All the perioperative complications are recorded.
Full Information
NCT ID
NCT05527314
First Posted
August 29, 2022
Last Updated
March 23, 2023
Sponsor
Second Affiliated Hospital of Nanchang University
1. Study Identification
Unique Protocol Identification Number
NCT05527314
Brief Title
Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
February 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Nanchang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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, 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation, Remimazolam, Sevoflurane, Pediatric Ophthalmic Surgery, Anesthesia, General
Keywords
Anesthesia, General, Pediatric ophthalmic surgery, Emergence Agitation, Remimazolam, Sevoflurane
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a RCTs.
Masking
ParticipantOutcomes Assessor
Masking Description
Care provider and investigator (anesthesiologist) cannot be blinded for different appearance of sevoflurane and remimazolam.
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remimazolam
Arm Type
Experimental
Arm Description
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.
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 %.
Arm Title
Sevoflorane
Arm Type
Active Comparator
Arm Description
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.
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 %.
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.
Intervention Type
Drug
Intervention Name(s)
Cisatracurium Besylate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery.
Primary Outcome Measure Information:
Title
The incidence of emergence agitation
Description
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.
Time Frame
Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
Title
The incidence of emergence agitation
Description
The Watcha scale consists of four items and scores >2 at any time indicates presence 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
Title
The incidence of emergence agitation
Description
The 5-point scale consists of five items. The scores ≥4 and lasts for more than 5 minutes indicate presence 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
Secondary Outcome Measure Information:
Title
Systolic pressure
Description
"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".
Time Frame
Up to 5 hours including preoperative, intraoperative, and postoperative periods
Title
Diastolic pressure
Description
"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".
Time Frame
Up to 5 hours including preoperative, intraoperative, and postoperative periods
Title
Mean pressure
Description
"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".
Time Frame
Up to 5 hours including preoperative, intraoperative, and postoperative periods
Title
Heart rate
Description
"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".
Time Frame
Up to 5 hours including preoperative, intraoperative, and postoperative periods
Title
Recovery times
Description
The period from discontinuation of anesthetic drugs to the recovery of the child's self-consciousness and can respond correctly to external stimuli.
Time Frame
Up to 30 minutes after operation
Title
Delayed emergence
Description
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
Time Frame
Up to 30 minutes after operation
Title
Postoperative Pain
Description
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.
Time Frame
During the recovery from anesthesia.
Title
Complication
Description
All the perioperative complications are recorded.
Time Frame
During the perioperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA Ⅰ-Ⅱ
Aged 3-8 years, weight > 10 kg, sex was not limited；
Children were scheduled for selective ophthalmic surgery under general anesthesia,
Exclusion Criteria:
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.
Facility Information:
Facility Name
the Second Affiliated Hospital of Nanchang University, Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
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