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

March 23, 2023 updated by: Fuzhou Hua, Second Affiliated Hospital of Nanchang University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China
        • the Second Affiliated Hospital of Nanchang University, Nanchang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 %.
Drug: 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.
Drug: Fentanyl
Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.
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.
Drug: Remifentanil
After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery.
Active Comparator: 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 %.
Drug: Fentanyl
Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.
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.
Drug: Remifentanil
After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence 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
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
Time Frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
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
Time Frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic pressure
Time Frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
"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".
Up to 5 hours including preoperative, intraoperative, and postoperative periods
Diastolic pressure
Time Frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
"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".
Up to 5 hours including preoperative, intraoperative, and postoperative periods
Mean pressure
Time Frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
"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".
Up to 5 hours including preoperative, intraoperative, and postoperative periods
Heart rate
Time Frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
"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".
Up to 5 hours including preoperative, intraoperative, and postoperative periods
Recovery times
Time Frame: Up to 30 minutes after operation
The period from discontinuation of anesthetic drugs to the recovery of the child's self-consciousness and can respond correctly to external stimuli.
Up to 30 minutes after operation
Delayed emergence
Time Frame: Up to 30 minutes after operation
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
Up to 30 minutes after operation
Postoperative Pain
Time Frame: During the recovery from anesthesia.
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.
During the recovery from anesthesia.
Complication
Time Frame: During the perioperative period
All the perioperative complications are recorded.
During the perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2022

Primary Completion (Actual)

February 6, 2023

Study Completion (Actual)

February 7, 2023

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-EA-1

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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