Clinical trial NCT05527314: 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
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Agitation
Remimazolam
Sevoflurane
Pediatric Ophthalmic Surgery
Anesthesia, General
Keywords: Anesthesia, General
Pediatric ophthalmic surgery
Emergence Agitation
Remimazolam
Sevoflurane
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 110
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a RCTs.
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

1. ASA Ⅰ-Ⅱ
2. Aged 3-8 years, weight \> 10 kg, sex was not limited；
3. Children were scheduled for selective ophthalmic surgery under general anesthesia,

Exclusion Criteria:

1. Respiratory infection was present within 4 weeks before surgery.
2. Potential or presence of difficult airways, airway obstruction, sleep apnea, and other contraindications to general anesthesia.
3. The blood routine or blood biochemical indexes were obviously abnormal.
4. Allergy or hypersensitive reaction to test drug, including remimazolam, sevoflurane, and remifentanil.
5. Any child who has taken benzodiazepines in the last 3 months.
6. Unable to cooperate to complete the test, and the guardian refused to attend.
7. Other reasons that researchers hold it is not appropriate to participate in this trial.

Primary outcomes:
measure: The incidence of emergence agitation
timeFrame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
measure: The incidence of emergence agitation
timeFrame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
measure: The incidence of emergence agitation
timeFrame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
Secondary outcomes:
measure: Systolic pressure
timeFrame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
measure: Diastolic pressure
timeFrame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
measure: Mean pressure
timeFrame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
measure: Heart rate
timeFrame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
measure: Recovery times
timeFrame: Up to 30 minutes after operation
measure: Delayed emergence
timeFrame: Up to 30 minutes after operation
measure: Postoperative Pain
timeFrame: During the recovery from anesthesia.
measure: Complication
timeFrame: During the perioperative period
Other outcomes:
Locations:
city: Nanchang
country: China
facility: the Second Affiliated Hospital of Nanchang University, Nanchang University
state: Jiangxi
Study officials:
References: