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

NCT ID: NCT05527314

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2023-02-07

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Remimazolam

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 %.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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.

Fentanyl

Intervention Type: DRUG

Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.

Cisatracurium Besylate

Intervention Type: DRUG

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.

Remifentanil

Intervention Type: DRUG

After the LoC, remifentanil 0.1\~0.3 ug/kg/min inject intravenously until the end of surgery.

Sevoflorane

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 %.

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

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.

Fentanyl

Intervention Type: DRUG

Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.

Cisatracurium Besylate

Intervention Type: DRUG

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.

Remifentanil

Intervention Type: DRUG

After the LoC, remifentanil 0.1\~0.3 ug/kg/min inject intravenously until the end of surgery.

Interventions

Remimazolam

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

Sevoflurane

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

Fentanyl

Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.

Intervention Type: DRUG

Cisatracurium Besylate

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

Remifentanil

After the LoC, remifentanil 0.1\~0.3 ug/kg/min inject intravenously until the end of surgery.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Fuzhou Hua

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Second Affiliated Hospital of Nanchang University, Nanchang University

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

2022-EA-1

Identifier Type: -

Identifier Source: org_study_id