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Completed

NCT Number: NCT05527314

Effect of Remimazolam vs Sevoflurane 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).

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Key information

Conditions

Emergence Agitation Anesthesia, General Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Ophthalmic Surgery Postoperative Complications Remimazolam Sevoflurane Signs and Symptoms

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Second Affiliated Hospital of Nanchang University, Nanchang University

Nanchang, Jiangxi, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Fentanyl

Drug

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

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.

Remifentanil

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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".

  2. 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".

  3. 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".

  4. 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".

  5. 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.

  6. 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.

  7. 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.

  8. Complication

    Time frame: During the perioperative period

    All the perioperative complications are recorded.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2022
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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