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

NCT05527314 | Completed

• 1 other identifier: 2022-EA-1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

Anesthesia, General; Pediatric ophthalmic surgery; Emergence Agitation; Remimazolam; Sevoflurane

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  Up to 5 hours including preoperative, intraoperative, and postoperative periods

• Diastolic pressure

  Up to 5 hours including preoperative, intraoperative, and postoperative periods

• Mean pressure

  Up to 5 hours including preoperative, intraoperative, and postoperative periods

• Heart rate

  Up to 5 hours including preoperative, intraoperative, and postoperative periods

• Recovery times

  Up to 30 minutes after operation

Study Arms (2)

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 %.

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 %.

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

Interventions

Remimazolam 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.

Remimazolam

Sevoflurane 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.

Sevoflorane

Fentanyl DRUG

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

Remimazolam; Sevoflorane

Cisatracurium Besylate 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.

Remimazolam; Sevoflorane

Remifentanil DRUG

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

Remimazolam; Sevoflorane

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

the Second Affiliated Hospital of Nanchang University, Nanchang University

Nanchang, Jiangxi, China

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

remimazolam; Sevoflurane; Fentanyl; cisatracurium; Remifentanil

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Care provider and investigator (anesthesiologist) cannot be blinded for different appearance of sevoflurane and remimazolam.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This is a RCTs.

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 2, 2022
• Study Start: August 23, 2022
• Primary Completion: February 6, 2023
• Study Completion: February 7, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

CN (1)