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

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527314
• Other study ID #: 2022-EA-1
• Status: Completed
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: February 7, 2023

Study information

• Verified date: March 2023
• Source: Second Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 7, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

1. ASA ?-?

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.

Related Conditions & MeSH terms

• Anesthesia, General
• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation
• Remimazolam
• Sevoflurane

Intervention

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.
• 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.
• Fentanyl
Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.
• 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.
• Remifentanil
After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery.

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Nanchang University, Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Systolic pressure	"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
Secondary	Diastolic pressure	"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
Secondary	Mean pressure	"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
Secondary	Heart rate	"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
Secondary	Recovery times	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
Secondary	Delayed emergence	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
Secondary	Postoperative Pain	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.
Secondary	Complication	All the perioperative complications are recorded.	During the perioperative period