Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery

Nanchang University

Status: Completed

Conditions: Remimazolam; Emergence Agitation; Pediatric Ophthalmic Surgery; Anesthesia, General; Sevoflurane

Treatments: Drug: Remimazolam; Drug: Sevoflurane; Drug: Cisatracurium Besylate; Drug: Fentanyl; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT05527314

2022-EA-1

Details and patient eligibility

About

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).

Enrollment: 110 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Remimazolam

Experimental group

Description:

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 %.

Treatment:

Drug: Remimazolam

Drug: Remifentanil

Drug: Cisatracurium Besylate

Drug: Fentanyl

Sevoflorane

Active Comparator group

Description:

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 %.

Treatment:

Drug: Remifentanil

Drug: Cisatracurium Besylate

Drug: Fentanyl

Drug: Sevoflurane